Quality Assurance & Regulatory Affairs

Our Quality Assurance (QA) and Regulatory Affairs (RA) team comprises a wealth of experience in all areas of drug development, approvals and manufacturing and can extend support for a diverse range of services including:

• Regulatory Dossier preparation (NDA/ANDA)
• GxP compliance audits of CROs, Manufacturing and Clinical Research Sites
• Regulatory Affairs support for post submission query resolution and   responses to facilitate successful approvals
• Dossier / Report preparation in E3 and eCTD formats

Our QA and RA team is committed to ensuring strict compliance to regulatory standards and our dedication to high quality, accurate results ensures the prompt and successful approval of our customer’s innovative products.

Quality Assurance is responsible for ensuring that all projects are conducted in compliance with Study Protocol, Operating Procedures and Regulatory & Ethical guidelines. QA also ensures document control and oversees organizational training is inline with stated objectives.

Infrastructure

• Archival of all study data and reports in an access controlled fire proof archival facility