From Research to Regulation: Diverse Types of Medical Writing Documents

by | Feb 20, 2024 | Medical Writing

Medical Writing Services

Medical writing plays a pivotal role in conveying medical information and research findings, addressing diverse needs within the healthcare and pharmaceutical sectors. This field encompasses a variety of documents, each serving specific purposes, from regulatory submissions and clinical research documentation to educational material and scientific publications. Here’s a closer look at our medical writing services and what kind of medical writing documents we provide:

Clinical Research Documents

Clinical Trial Protocols: These documents outline the objective, design, methodology, statistical considerations, and organization of a clinical trial, providing a roadmap for conducting the study.

Informed Consent Forms: Essential for clinical trials, these forms provide participants with information about the study, including its purpose, procedures, risks, benefits, and their rights as participants.

Clinical Study Reports (CSRs): Prepared after completing a clinical trial, CSRs present the methodology, results, and conclusions of the trial, comprehensively serving as a detailed record of the trial and its outcomes.

Patient Information Leaflets (PILs) and Summary of Product Characteristics (SmPCs): These are regulatory documents required for the marketing approval of a drug. PILs inform patients about how to use a medication, while SmPCs provide detailed information for healthcare professionals on how to prescribe it.

Regulatory Documents

Investigational New Drug (IND) Applications: These documents are submitted to regulatory authorities to obtain permission to initiate clinical trials with a new drug.

New Drug Applications (NDA)/Marketing Authorization Applications (MAA): Submitted to regulatory authorities to seek approval for marketing a new pharmaceutical for sale and use.

Periodic Safety Update Reports (PSURs): These reports offer updates on the safety profile of a pharmaceutical product, including any new risks identified.

Scientific Publications

Research Articles: These are detailed studies reporting original research, published in scientific journals.

Review Articles: Articles that summarize current research on a particular topic.

Case Reports: Detailed reports on the symptoms, diagnosis, treatment, and follow-up of an individual patient.

Abstracts and Posters for Scientific Conferences: Concise summaries of research findings presented at scientific meetings.

Educational Materials

Continuing Medical Education (CME) Materials: Designed to educate healthcare professionals about the latest developments in their field.

Patient Education Materials: Written in accessible language, these materials inform patients about their health conditions, treatment options, and healthy lifestyle choices.

Medico-Marketing Documents

Product Monographs: Detailed information about a drug, including its properties, indications, contraindications, side effects, etc.

Sales Training Manuals: Materials created to train sales representatives about the medical and scientific aspects of the products they will be selling.

Advertising Copy: Writing promotional materials targeting healthcare professionals or the public, adhering to regulatory standards.

Health Policy Documents

Health Technology Assessments (HTAs): Evaluations of the social, economic, organizational, and ethical issues of a health intervention or health technology.

Policy Briefs: Documents providing evidence-based recommendations on health policy issues to policymakers.

Turacoz Group is a leading medical writing agency and we provide different kinds of medical writing and academic writing services. If you are looking for a medical writer, you are at the right place. With us, you will get assistance with regulatory medical writing, research paper writing, academic writing, etc. We also provide medical and regulatory writing courses that are designed to equip you with essential skills and insights to excel in the dynamic healthcare industry. If you are intrigued by the world of medical writing and eager to learn how to create various document types, explore our “Comprehensive Certificate Course in Medical Writing.” Start your journey towards becoming a skilled medical writer today. 

Reach out to us at trainings@turacoz.com and elevate your expertise now!

Registration link: https://forms.office.com/pages/responsepage.aspx?id=TCiDEIoeEUeaAGbcYpnFeedjbeZ6M2hImsjsFwldXtdUNEpRVVlMRzZKUlpLTE1MUDA2NUdRQ0JVVC4u

Loading...

Ashish Pandey

Sr. Manager - Business Growth, Turacoz Healthcare Solutions

Ashish is a experienced healthcare professional with over 14 years of experience in driving sales and business development within the dynamic healthcare industry. He specializes in B2B consultative selling and building strong, lasting relationships with clients.

He has a proven track record of building and leading high-performing teams, fostering collaborative environments where diverse talents shine and consistently meeting Business goals. This drive extends to strategic planning, where his keen understanding of the healthcare market translates into impactful sales strategies that achieve ambitious growth objectives. He possesses a deep commitment to continuous learning and development, ensuring he stays at the forefront of the ever-evolving healthcare landscape.

This passion isn't limited to professional pursuits, Ashish is an adventurous spirit, seeking new experiences. He has participated in various marathons, regularly cycles, and embarks on frequent trekking adventures, exploring new challenges while chasing breathtaking landscapes.

Ashish's combination of professional expertise, unwavering dedication, and adventurous spirit makes him an asset. He is a results-oriented leader who thrives in dynamic environments and is always eager to learn, grow, and explore the world around him.

So, whether it's navigating the complexities of the healthcare industry or scaling a new mountain peak, Ashish approaches everything with the same unwavering dedication, passion, and a drive to explore.

If you are seeking a results-driven professional with a proven track record in driving business growth and a commitment to customer satisfaction, Ashish would be delighted to connect and explore potential business opportunities.

Shruti

Senior Medical Writer, Turacoz Healthcare Solutions

Shruti, is a experienced medical writer at Turacoz, brings over seven years of expertise to the table. From crafting compelling publications to facilitating advisory board meetings, she excels in navigating the complexities of the healthcare landscape. Shruti's ability to distill intricate clinical data into clear, concise communications sets her apart. She fosters a collaborative environment, mentoring junior colleagues and seamlessly integrating with project managers. Diligent and adaptable, Shruti ensures timely delivery of high-quality work, all while embracing creativity. Beyond her professional endeavors, she finds solace in reading and exploring the great outdoors. Shruti's professionalism and collaborative spirit make her an invaluable asset to any team.

Rohit Arora

Rohit Arora

Deputy Manager, Project Management

Rohit Arora, our Deputy Manager - Project Management, is based in Delhi-NCR and has overall experience of more than 20 years in the US Healthcare Industry and Teleradiology. He started his career as an AAPC Certified Coding Professional in Surgery and Emergency Department Domains, working directly with doctors in the US. He soon climbed up the ladder and became a Senior Manager handling Operations, Vendor Management and Client Coordination in various reputed Healthcare Organizations. With his sheer sincerity and passion, Rohit has come a long way in the healthcare industry despite being a commerce graduate. A few of the organizations, Rohit has worked with previously are - Synapsica Healthcare Pvt. Ltd., Access Healthcare (previously known as Pacific BPO).
On the personal front, Rohit is a foodie. He wants to travel to as many places in his life and be close to nature as much as possible. He loves to spend time with his family and gives himself a spiritual detox whenever possible to squeeze out time from his busy schedule.

Isha Gupta

Account Manager, Turacoz Healthcare Solutions

Isha Gupta is a confident woman with experience of more than eight years in Client Servicing and Project Management. She has been working with Turacoz Healthcare Solutions for the past two years in the Project Management department, where she handles critical projects related to Medico-Marketing. Coming to her educational background, Isha is a B. tech in Biotechnology. Some of her interests other than work are listening to music and exploring new places.

Atul Teotia

Atul Teotia

Sr. Digital Transformation Specialist, Turacoz Healthcare Solutions

Atul Kumar is a Sr. Digital Transformation Specialist with over seven years of experience in Software development roles. His journey as a junior PHP developer started five years back and at Turacoz, he has had a key role in creating our employee/resource management system. Atul had done his Master’s in Computer Applications from AKTU and got his bachelor’s degree in the same subject from CCSU. Besides work, Atul really enjoys bike riding, playing badminton, listening to music, and watching movies. He also loves to explore the Himalayas.

 

Pallavi Kulkarni

Lead Creative Designer

Discover the expertise of Ms. Pallavi, an experienced graphic designer with over 12 years of diverse experience across multiple graphic sectors. Having dedicated nearly 4 years to Turacoz, Pallavi finds immense satisfaction in her work. At Turacoz, she revels in a conducive environment brimming with growth opportunities, creative exploration, and managerial support to tackle diverse project challenges. Striking a harmonious balance between work and family life, Pallavi finds time to indulge in her hobbies such as music, gardening, and reading. Join Pallavi and experience a fulfilling journey of creativity, growth, and work-life balance at Turacoz.

Harshita Gupta

Harshita Gupta

Business Development Associate

Harshita did her bachelor's in healthcare management and thereafter, pursued MBA in Marketing from NMIMS (Mumbai), given her interest in the field. She has been associated with Turacoz for the past two and a half years as a Senior Business Development Associate. With her excellent communication skills, she has been acquiring business from key companies across the globe. She is a team player and believes in growing together with the team. As far as her interests are concerned, she loves travelling and connecting with new people which is primarily why she entered the field of business development and marketing. As a person, she is very dynamic with a solution-oriented mindset and loves to apply her creativity in helping her clients achieve their scientific communication objectives. She loves to build new connections and bond with them over a quick coffee chat!

Neelima Pusala

Neelima Pusala

Lead Associate- Business Growth Unit, Turacoz Healthcare Solutions

Neelima completed her M. Pharmacy from VCOP, Warangal, and did her B. Pharm from Kakatiya University. She is an International Business Development professional with experience in the Scientific and Medical Communication industry. She has rich exposure in Business, Negotiations, Partner Relationship Management, Key Account Management, B2B Sales and Business Strategy and Processes, etc. But when she is not at work, the thing she likes to do the most is spending time and travel with family. She loves learning new skills, and recently, she has developed an interest in exploring clinical SAS as they help her explore her new zeal for programming.

Chinthana Bhat

Chinthana Bhat

Sr. Associate - Project Excellence Unit, Turacoz Healthcare Solutions

Chinthana has more than 10 years of experience in the information service-based industry as a senior scientific analyst. At Turacoz Healthcare Solutions, she is a dedicated full-time Project management associate for global client-based projects and a mentor for junior managers. In a span of two-and-a-half years, she has managed around 20 different pharma-based clients across the globe with client appreciation and repeated business. The services she has handled include end-to-end Advisory Board meeting support, medical communication projects – CSR, manuscript and publications, medico marketing documents, website content for an encyclopedia etc. By qualification, Chinthana is an MSc in Biotechnology. She also did her bachelor’s in the same subject from St Aloysius College, Mangalore. Her hobbies include listening to music, solving puzzles, watching movies, web series, and reading books.

Mansi Mishra

Lead Medical Writer,Turacoz Healthcare Solutions

Mansi Mishra is a dedicated full-time medical writer at Turacoz from 2020 and comes with more than nine years of experience in content management, digital content development, healthcare writing and editing across several therapeutic areas. She pursued her graduation in Biotechnology from Amity University, Noida, and her creative flair and inclination towards writing got her into the medical communications field. Mansi has an empathetic and positive attitude toward work and life. Besides being an avid fiction reader, she loves to travel and explore new places. She likes to try her hands on new recipes, dance, paint, or simply binge-watch shows or movies in her leisure time.

Ashima Jawa

Ashima Jawa

Sr. Executive Assistant & Human Resource, Turacoz Healthcare Solutions

With over eight years of dedicated service in Executive Assistant and Human Resource positions, Ashima embodies excellence and proficiency in every aspect of her work. Her extensive tenure in high-pressure environments has finely tuned her ability to consistently deliver exceptional results.

Ashima's expertise extends across various domains, from providing strategic advice to operational managers and overseeing administrative functions in complex organizations to nurturing company culture and mediating disputes. Her deep understanding of office management ensures seamless operations, with efficient handling of inquiries, consultations, and timely access to resources for employees, compliance teams, clients, and beyond. Since joining Turacoz in 2019, Ashima has become an indispensable member of the team. Collaborating closely with Turacoz Group Directors, she provides invaluable technical and logistical support. Her warm and collaborative demeanor makes her a beloved team player, enhancing the overall work environment.

Prior to her role at Turacoz, Ashima served as Assistant Manager at ILSI-India, where she showcased her leadership capabilities while working with government officials and various organizations. Beyond her professional pursuits, Ashima finds joy in traveling and cherishing moments with her loved ones. Embark on a journey with Ashima and experience the essence of dedication, expertise, and teamwork. Explore how her wealth of experience and unwavering commitment elevate every endeavor.

Diya Revankar

Diya Revankar

Creative Associate, Turacoz Healthcare Solutions

Diya is a seasoned graphic designer and follows her passion towards the art in a professional capacity. She has over 11 years of designing experience with medical communication companies and she says associating with Turacoz has been a wholesome experience for her when it comes to exploring new opportunities. Besides her professional interests, Diya is passionate about cooking and loves to spend quality time with her son.

Dr. Anindita Majumdar

Dr. Anindita Majumdar

Lead QC Specialist, Turacoz Healthcare Solutions

Born a Bengali, Dr. Anindita Majumdar was raised in the steel city of Bhilai, Chhattisgarh, where she saw people from all corners of the country with diverse castes, cultures, and religions staying together. She says it felt like pure heaven as they celebrated all the festivals together. From there, she moved to Maharashtra where she did her PhD in Biochemistry from the Mahatma Gandhi Institute of Medical Sciences and spent over 10 years of her life. Next, she moved to Puducherry and has been living there for the past decade. Dr. Anindita’s hobbies include reading, cooking, sports, and travelling. An interesting thing about her is that she was a state-level badminton player and represented her state during school days. At present, Dr. Anindita is also a volunteer for Help Age India and hopes to grow in her chosen area as she wants to maximize her potential each day with her hard work, experiences, and continuous learning!

Varun Kumar Kosaraju

Varun Kumar Kosaraju

Account Manager, Turacoz Healthcare Solutions

Varun Kumar Kosaraju is an expert in the field of Program and Project Management. He graduated in Information Technology but was inclined towards Project Management and this is what led him further in this field. Varun has a demonstrated history of working in the medical communications sector and has been working with Turacoz Healthcare Solutions for the past one-and-a-half years as a Project Management Associate where he is focused on learning new things each day. Some of Varun’s interests, outside of work, are dancing and exploring new places.

Shweta Tripathi

Shweta Tripathi

Medical Writer 1, Turacoz Healthcare Solutions

Shweta has expertise in managing Veeva Vault and Medical Review process. Before taking this job, Shweta had an experience of nine years as a Plant Scientist researching the role of genes and their environmental interaction. She is a quick learner, loves to work on diverse projects and is committed to her Job. A PhD. by qualification with a specialization in life sciences, she is also a mother of a baby girl. Shweta has a wide range of interests and enjoys learning about gadgets. She is passionate about travelling and is a trained Kathak dancer too.

Dr. Ritu Sharma

Technical Solution Manager,Turacoz Healthcare Solutions

Dr. Ritu Sharma is a doctor with an MBA degree and over 15 years of experience in various medical domains. She started her career with Dabur as Clinical Research Associate and later worked for the Oncology Therapy area in competitive intelligence. She has headed medical writing and communication projects for Oncology, Nutraceuticals, Hematology, CNS, CVS, etc. to name a few. Apart from being a seasoned professional, her family keeps her busy and motivated. She loves Bollywood dance, drama, comedy, and romance. ‘Enjoy & let others enjoy’ is her life motto.

Dr. Aparna H Gopalkrishna

Dr. Aparna H Gopalkrishna

MDS, Oral and Maxillofacial Pathology
Medical Reviewer and Team Lead, Turacoz Healthcare Solutions

With an overall experience of more than 15 years as a clinician, trainer, academician, and in labeling, Dr. Aparna feels quite passionate about medical communications. She has worked with several pharmaceutical MNCs to facilitate branding and new product launch and developed promotional content in various therapy areas for better reach and acceptability. She believes that good planning and the right execution can prove to be the only armor to deliver the best quality work even with the most challenging timelines. Besides work, Dr. Aparna loves to travel and explore new places, food, and trek whenever possible. A good book or binge-watching are her other go-to alternatives. Also, she likes to give back a little bit to society and engage in activities that enable her to reach out to people and help them.

Somdatta Mukherjee

Somdatta Mukherjee

Lead Medical Writer, Turacoz Healthcare Solutions

Somdatta Mukherjee is an accomplished medical writer with experience of more than six years in this field. Currently, she is working as a lead medical writer at Turacoz Healthcare Solutions. She earned her MS degree in Cell and Molecular Biology from Fordham University, New York, USA, and worked as a Research Teaching Specialist at Rutgers University, New Jersey, USA. Writing about health and medicine is her passion and she enjoys using her skills to support the publication writing department at Turacoz. Besides her professional interests, her other passion is travelling to exotic places and spending quality time with her family.

Ankita Mistry

Ankita Mistry

Medical Writer 1, Turacoz Healthcare Solutions

Ankita is a firm believer that being proactive and taking responsibility is something which will take you higher in life. She is a passionate and dedicated full-time medical writer at Turacoz Healthcare Solutions with a total experience of seven years in writing. Ankita is a pharmacist by qualification with a master’s degree in Pharmaceutics from the University of Mumbai. Other than work, she loves dancing, painting, and exploring skincare options and makeup.

Dr. Kavita S. Shenoy

Dr. Kavita S. Shenoy

Medical Writer 2, Turacoz Healthcare Solutions

Kavita is a B.H.M.S doctor with over 15 years of experience in diverse medico-marketing roles. Her journey as a medical writer started seven years back after a maternity hiatus. For her, it has been a challenging and enriching experience since then. Besides her work, she enjoys travelling, listening to music, and watching movies. Kavita says, she is also a foodie and loves exploring new restaurants.

Anshu Chauhan

Anshu Chauhan

Associate Director - Project Excellence Unit

Anshu Chauhan is a PMP, Prince2 and Six sigma trained professional and a trusted leader with a demonstrated history of working in the Healthcare industry. A Project Manager with more than 16 years of experience, she is skilled in CRO Management, Regulatory Affairs, Medical Writing, and Medico- Marketing. She is a leader who enjoys challenges and works hard to fulfil them even in unusual scenarios. She is an ardent believer of “Motivation is the key to success’ and promotes establishment of a motivating environment for every team member. Her zeal to work till perfection boosts the team to succeed and deliver exceptional business outcomes. She is always committed to build and promote strategies that produce quality outcomes for the company. She is the one who keeps calm even in crisis and has a remarkable track record of delivering time-sensitive projects under pressure and within limited budget. With all the skills, she has overseen a range of critical projects from conception to delivery. Her way of striking a perfect balance between stakeholders and company is commendable. She believes in teamwork and works in close collaboration with the team members to create and manage the accounts of prestigious international brands and clients.

She loves her work and confidently takes every step to improvise and strengthen her capabilities. Besides her professional interests, she is a traveller and enjoys quick getaways to exotic places to spend some quality time with family and friends.

Dr Shruti Banerjee Shah

Dr Shruti Banerjee Shah

Director, Strategy & Growth

Dr. Shruti is a molecular oncology expert, holding a doctorate from Mumbai University's Advanced Center for Training, Research and Education in Cancer. She is an active member of the International Society of Medical Publications Professionals (ISMPP) and boasts over 20 years of experience in scientific writing. With over 80 publications in medical and scientific journals and 150 congress presentations under her belt, she is a seasoned pro in the field. Her 3+ years of experience in regulatory medical writing for leading pharmaceutical companies (phase 2/3 studies), combined with her background in pharmacokinetics/pharmacodynamic studies and training in clinical research, project management, and quality assurance make her an invaluable asset to Turacoz Healthcare Solutions.

As the leader of Turacoz's technical medical writing team, she is responsible for the technical accuracy and quality of all client deliverables and provides guidance and training on publishing papers and various forms of scientific writing. Her strategies for building strong client relationships and creating effective medical content are second to none. When she's not revolutionizing the world of medical writing, Dr. Shruti is an avid fitness enthusiast, tackling marathons and ultra-marathons, trekking in the Himalayas, and even dabbling in urban farming managing her small vegetable garden and hydroponics to grow exotic vegetables. She also finds time to paint canvases and backpack through mountains and meadows.

Dr. Namrata Singh

Founder & Director, Turacoz Group

Dr. Namrata is a woman of determination and resilience, living by the mantra that "nothing is impossible." With a wealth of experience as a paediatrician and medical writer, she possesses the unique ability to effectively communicate complex medical concepts to a wide range of audiences. As Director of Medical Services, she leads her team with a steady hand, always willing to go the extra mile to mentor and guide new team members. When she's not healing young patients or busy in business, she indulges in her love for cooking. She dreams of opening a chain of healthy food joints one day and conducting lifestyle modification sessions for kids and teenagers. Dr. Namrata is a true leader and a constant inspiration to those around her.

Divya Pal Singh

Divya Pal Singh

Founder & Director, Turacoz Group

DP Singh is a computer science graduate from NIT Calicut, batch of 1986-90. He later pursued LLB in 1995 and received on-the-job software training in 1995-96, working on multiple platforms. After gaining valuable industry experience, he decided to further his education and completed an MBA. In 2000, he took the entrepreneurial leap and established a self-funded college in Meerut. He also runs an Engineering college, school, degree college, and Management college. He wears many hats as an educationist and entrepreneur. In 2014, he along with Dr Namrata co-founded Turacoz and has been majorly providing software support ever since. He also created a Resource Management System for the company from scratch.

In his free time, DP Singh likes to delve into the deeper aspects of life, such as spirituality and philosophy. He is an avid reader and listener of motivational material. He hopes to become a motivational speaker and leave a lasting impact on society through his work and education initiatives.

Arushi Sharma

Arushi Sharma

Project Management Associate

I started my journey with Turacoz in 2021 as a Project Management Trainee, and since then, I've grown a lot, both knowledge-wise and skill-wise. The company has given me many opportunities to widen my knowledge and for this, I will forever be grateful. I enjoy working here because of the positive work culture and super supportive colleagues. Turacoz is a great place to work and could be a life-changing opportunity for people who would like to achieve a great career.

Mansi Mishra

Mansi Mishra

Lead Medical Writer

I am going to complete three years at Turacoz, and I am still learning! The organization has given me great opportunities to learn and work for the best and the brightest with a room for growth and development, while working from home. Turacoz has a friendly, supportive, and collaborative work culture, with wonderful people across all the teams who always support and help each other. The projects are diverse and highly stimulating and can really help one hone their medical writing skills and eventually acquire expertise in several types of medical communication documents across different therapeutic areas.

Parul Jain

Parul Jain

Content Writer

Turacoz is a place which gave me the opportunity to merge my profession and interest. An organization where learning never ends, is Turacoz. From managers to team members, everyone is eager to guide and aid each other in their growth. The most amazing quality of Turacoz is diversity, people from different parts of the world are working together with so much enthusiasm. I am learning wonderful things about medical writing, people, and myself every day. I am glad to be part of a team where ideas are respected, and vision is celebrated. Perfection, People and Planet, this organization is allowing me to grow in every dimension. Cheers to Turacoz!

Shribhagwan Verma

Shribhagwan Verma

Sr. Market Research Analyst

For me, it's been almost 4.5 years in Turacoz. Turacoz has provided me with a platform to learn, evolve, and constantly evaluate my progress. Turacoz values 'hard work' & 'quality' that makes you more responsible at work. The founders and management team are open to discussing new ideas and improvements. I enjoy a very good work-life balance here. Every employee is always given a chance to share his/her problems, which helps to establish a healthy relationship. I am glad to be a part of this company and a wonderful young team!