What We Do

Creating & Sustaining Durable Generic Pharma Associations

Our Broad Business Model

Firmlink’s Vendor Boundary Conditions

  • Must have a PIC approvable site.
  • Have niche products not requiring Bioequivalence Studies; Hepatitis C; Oncology Injectables; Speciality Injectables; Opthalmic Drops; Inhalers; Patches; Medical/Diagnostic Devices.
  • Or if Oral Solids – have differentiated / value-added OSD with BEs.
  • Piggy-back on existing regulated projects.
  • Dossier development capability.
  • Global mindset.
  • Flexibility of batch size and packaging.

Key Successes

  • Maximum site approvals (17) arranged by any company thru TFDA, Taiwan.
  • Pioneer company to arrange for FDA, Philippines; FDA, Taiwan ; BPOM, Indonesia and ANVISA approvals in Bangladesh and India
  • 220 + Product filings done with Phil. FDA of which over 120 approvals at an average of 14.2 months.
  • 124 products signed in with Taiwanese companies – maximum for any generic product organization.
  • Strong relations at the CXO level with 7 of the top 10 Bangladeshi players.
  • Signed Sourcing agreements with 75 vendors across geographies.
  • Leading Brands launched from Firmlink stable in Philippines, Taiwan, Vietnam, Indonesia & Bangladesh.
  • Licensed Products with partners in Korea , EU , Taiwan, South Africa , Indonesia & Australia.
  • Supply arrangements with 7 major leading players in Philippines.

Our Deliverables

  • Finding ideal, accredited sourcing partners.
  • Sourcing difficult to formulate / manufacture product : Hep C ; inhalers; patches; onco; medical devices, etc.
  • Site approvals from TFDA/PFDA/BPOM/ANVISA/ customer audits.
  • Tripartite agreement signing.
  • Product dossier vetting and filing.
  • Product approvals / MA’s.
  • Negotiations driven to maximize market realizations to make it attractive for all parties.
  • Ensuring reliability of supplies.
  • Licensing agreements.