Regulatory Affairs

The regulatory affair team of GBC is responsible for ensuring that the production of GBC’s products in line with national regulatory requirements, and provide registration services for contract manufacture drug products.
- Active Pharmaceutical Ingredients (API)
- Drug Product
  • Peptide
  • Synthetic Peptide
  • Biologics
  • Oncology
  • Others (small molecules)
Registration services
- Prepare Common Technical Documents (CTD) and complete the registrations of drug substance and drug products in the intended regulatory authorities
  • Export permit application for drug substance
  • Export permit application for generic drug
  • Export permit application for biosimilar
  • Drug products registration for generic and biosimilars in other countries
  • - Assist registration and post approval maintenance for contract manufacture drug products
    - Continuously update and maintain the regulatory document, approved by regulatory authorities worldwide
    - Regulatory strategy planning for target market