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REGULATORY SERVICES

Doctor Checking a Form

At Gencorepharmaceuticals, we are aware that a pharmaceutical company's main priorities are expanding its product line and bringing new medications to market. Finding the proper partner to relieve the burden of meeting the requirements of Competent Authorities in aiding in the management of regulatory affairs is essential. Understanding the intricacies involved in handling pharmaceutical regulations can be a real problem.

Our clinical trial and third-party logistics services are available alone or in conjunction with our Singapore regulatory services. We are in a great position to connect pharmaceutical suppliers, regulatory experts, and Competent Authorities because to our constantly growing network of partnerships.

Laboratory

We can help with every stage of a product’s life, from supporting license applications to managing day to day regulatory issues, to whatever level you need:

  • Medical Information (MI) and Pharmacovigilance (PV)

  • Full Quality System Implementation

  • Licensing Authority applications

  • Wholesale Dealer Authorisation (WDA) applications

  • Site visits and auditing

  • Preparation of sites for inspections

  • Review & implementation of quality systems

  • Regulatory services UK

  • Qualified Person (QP) batch release

  • Liaison with competent authorities on all aspects of compliance

  • Analytical testing

  • GDP/GCP/GMP Expertise

  • Patient Information Testing

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