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Regulatory Affairs
> Post-Market Compliance
Acting as your virtual RA department, PharmEng utilizes a unique Market Access and Operational model that allows for independent license holding, authorizing distributors to import and supply. Acting as the MAH (Marketing Authorization Holder) or the PRH (Product Registrant Holder), we represent companies to register and hold product licenses without distributor risk or loss of brand control. In addition, companies also reduce the risk and expense of maintaining and managing its own RA department during the initial and marketing phase of market penetration, while undergoing product approval or manufacturing variation process and testing market feasibility.
Services
- Post-market Surveillance and Pharmacovigilance
- Periodic Safety Update Reports (PSUR)
- Adverse event reporting
- Field Safety Corrective Actions
- Local Literature Screening
- Life Cycle Variation submission
- Change Notifications
- Renewal applications
- GMP Clearance
- Manufacturing Site Transfers
- Technology Transfer
- Internal Audit support
- Conformity Assessment Audits
- Import & Wholesale License Application
- Quality System Management
Countries
- ASEAN: Singapore, Malaysia, Vietnam, Philippines, Myanmar, Cambodia
- Asia Pacific: Taiwan, Hong Kong, China, Korea, Australia, New Zealand, India, Bangladesh
