Turacoz provides regulatory support for pharma and healthcare sector in following ways:
- Regulatory Affairs and Consultancy: Consultancy in development and planning, submissions like IND, NDA, MAA, CTA, IMPD, IMDD, and labelling
- Clinical Research and Regulatory Writing: Documents preparation like protocols; informed consent forms (ICFs); case report forms (CRFs); clinical study reports (CSR); investigator’s brochure (IB); clinical overview (CO), non-clinical overview (NCO), clinical summary, and non-clinical summary of common technical document (CTD); clinical trial disclosures etc.
We take complete responsibility for on time and successful submissions. Our core strengths include both pre- and post-approval submission documents. We also expertise in specific quality check (QC) and quality assurance (QA) projects. We have thorough knowledge of various regulatory guidelines like that of United States Food and Drug Administration (US FDA); European Medicines Agency (EMA); Japanese Ministry of Health, Labour 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 and templates to create quality and regulatory compliant documents.