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Regulatory Affairs
> Regulatory Market Access
Acting as your virtual Regulatory Affairs department, Clients may access different levels of RA expertise for different countries of interest, via a single Project Management window. PharmEng offers a backend team of Subject Matter Experts (SME) to provide expert technical to administrative expertise, that are usually not present in one individual. Such a single window access offers companies much benefits and assurance that there is not only cost savings, but also professional review and continuity of projects as the team covers for individual absenteeism from work, to see through the product’s life cycle management from product development to approval, ensuring compliance along the way.
Services:
- Project Management
- Single window to multiple markets
- Virtual Regulatory Affairs representation
- Local Authorization Representation
- Product Registration Holder
- Product License Holding
- Cosmetic Notification Holder
- Marketing Authorization Transfers
- Establishment Registration
- Pharmacist License
- Local Person for Pharmacovigilance
- Import and Wholesale License application
- Outsourcing solutions
- In and out licensing
Countries:
- ASEAN: Singapore, Malaysia, Indonesia, Vietnam, Philippines, Myanmar, Cambodia
- Asia Pacific: Taiwan, Hong Kong, China, Korea, Australia, New Zealand, India, Bangladesh
