Regulatory Assistance

Overcoming Regulatory Challenges, Accelerated Registration

The pharmaceutical universe is a rapidly shifting and increasingly complicated environment. Drug administration and regulatory bodies across the globe – particularly pharmerging ones – are frequently changing standards and revising operating conditions. We at FIRMLINK have our fingers constantly on the pulse of these revisions ensuring that you get the benefits when filing your dossier.

FIRMLINK carries out an exhaustive evaluation of your dossier, assessing its strengths and weaknesses, identifying deficiencies and suggesting solutions. We help define and prepare a comprehensive regulatory strategy. As part of our Assistance Services we submit regular periodic reports on the dossier’s progress.

We vet, assess and guide plant master files and pharmaceutical dossiers through the regulatory channels. We closely monitor the progress of files; responding to queries; providing timely clarifications, thereby accelerating the entirle drug registration process.

The center of gravity of the global pharma business has moved to Asia. 10 of the top 15 pharmerging markets are expected to be in this region. FIRMLINK’s knowledge and uniquely long-term experience in navigating the bewildering regulatory mazes across the ASEAN and LATAM zones has given us the expertise to register products – really quickly.

Our proven predictive insights have led us to identify Brazil, Ukraine and Jordan as high growth areas. Flexibility, agility, speed and skill at executing strategy allows us to offer viable and innovative solutions all through the regulatory process. We apply a two-pronged regulatory approach: Harmonize with global IPR and upgrade quality standards for local populations.

Our consultants have extensive technical knowledge coupled with long-standing and beneficial relationships with members of key regulatory bodies. In effect, at the operational level, we are on top of the situation at every given step, providing efficient solutions. Our constantly expanding market reach enables us to provide comprehensive services to existing and potential partners.

FIRMLINK significantly improves product launch timelines. 

Our reliable and speedy regulatory assistance services ensure:

  • Dossiers meet all regulatory requirements
  • Plant Master file clearances
  • Guidance on pharmerging country regulations
  • Expert advice on rapidly shifting ASEAN Regulatory scene
  • Coordination of all regulatory procedures
  • Focus on rapidly launching & marketing a product