Porton has a highly experienced regulatory affairs team which provides CMC services at all research stages of Investigational New Drug application (IND/CTA) and its clinical trial phases (P1, P2, P3), New Drug Applications (NDA/MAA), Abbreviated New Drug Application (ANDA), and post-approval regulatory services including product change, annual report and re-registration service. We are strongly acquainted with regulatory expectations of all major global agencies such as USFDA, EMA, PMDA, NMPA and TGA.

We can provide comprehensive API life cycle service management ranging from late-phase clinical development to filing, post-approval commercial and end of exclusivity. Taking a proactive approach, our regulatory affairs group can provide gap analysis where required and relevant CMC data of Modules 2 and 3 of in CTD format and other formats required.

Services:

• Synchronous assessment, plan and feasibility consultation during critical CMC R&D
• Regulatory compliance guidance and support during critical CMC manufacturing
• Preparation, compilation and technical review for CMC filing materials
• ANDA filing in US, Europe, Japan, WHO and China (USDMF, CEP dossier, APIMF/MF)
• Pharmaceutical data registration support for IND, NDA, ANDA of biological products in NMPA
• Customized filing service for customized pharmaceutical products
• English and/or Chinese translation services for filing materials
• Assure filing quality to satisfy the submission requirements
• Submit materials and maintain good communications with the authorities.

With extensive API CMC filing experience throughout the world and as a Holder of multiple DMFs, Porton has submitted filings for over 30 products filed with all major regulatory bodies such as USFDA, EU EDQM, WHO, Japan PMDA, China NMPA, Canada TPD covering IND, NDA and ANDA submissions.

Porton has the manufacturing facilities, which has successfully passed the GMP site inspections conducted by US FDA, EU EMA, Japan PMDA and China NMPA.

SHARE :