With new regulations coming everyday and stringent regulatory requirements, pharmaceutical companies need regular advice on the legal and scientific requirements as well as support to get marketing authorization in different regions. Turacoz has a team of regulatory experts who can help in preparation of regulatory dossiers (as per different region requirements) and give strategic advice, right from the development phase of a product. Not only this, we keep ourselves up-to-date with new guidelines or updates, and ensure that the drug labels are compliant by creating, tracking, and updating labels, as and when required.
Turacoz provides support for pharma and healthcare sector in diverse ways: regulatory affairs and consultancy, regulatory writing, and safety reporting; for that we take complete responsibility for on-time and successful submissions. Our core strengths include both pre- and post-approval submission documents. We have expertise in specific quality check (QC) and quality assurance (QA) projects. We acquire vast knowledge of country-specific regulatory guidelines like that of United States Food and Drug Administration (US FDA); European Medicines Agency (EMA); Japanese Ministry of Health, Labor and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA); The Federal Institute for Drugs and Medical Devices (BfArM); Central Drugs Standard Control Organization (CDSCO) and Drug Controller General of India (DCGI); and Rest of the World (ROW). Moreover, our service spectrum covers all kind of products ranging from drugs and generics to biologics and biosimilars, diagnostics and medical devices, immunologics etc. We thoroughly follow ICH‑GCP guidelines, country-specific guidelines, and templates to produce quality and regulatory compliant documents for various products (ranging from drugs to medical devices, biologics and biosimilars, nutrition and dietary supplements, aesthetics and cosmetics etc.).