See All Services
>
Regulatory Affairs
> Pre-Market Submission Services
PharmEng offers you a solution to get your products to market where you do not have a local presence. PharmEng has over the years, screened and qualified our local Consultants, along with testimonials from our long term Clients, you can be assured that the Consultants and Affiliates or Partners we work with, will not disappoint with trust and reliability issues. Our network of Consultants and Affiliates and Project Managers will ensure that the license holding obligations and projects are seen through from start to finish with zero or minimal disruption and compliance issues, where such instances may be unforeseen.
Services
- Marketing Authorization Representation
- Engagement of subject matter experts
- Local language & English interface translation
- Country specific dossier and labeling translation
- Module 1 local administration preparation
- Dossier compliance review and submission
- Chemistry Manufacturing & Control CMC review
- Bio-Equivalence review and waiver
- eCTD / ACTD conversion
- Drug Master file application
- Regulatory agency meetings and feedback
- Manufacturer Site Inspection
- GMP / ISO 13485 quality audit inspections
- GDP supplier audit inspections
- Common Submission Dossier Template
- Cosmetic Product Information File
- Toxicology Assessment
Countries
- ASEAN: Singapore, Malaysia, Indonesia, Vietnam, Philippines, Myanmar, Cambodia
- Asia Pacific: Taiwan, Hong Kong, China, Korea, Australia, New Zealand, India, Bangladesh
