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Regulatory Assistance

As medical boundaries get pushed further so does the requirement for ever more innovative pharmaceutical products. In a constantly evolving situation drug administration and regulatory bodies across the globe – and particularly the pharmerging ones – are frequently changing interpretations, standards and updating operating conditions to stay abreast of global developments.

Firmlink will provide in-depth evaluation of your dossier, assessing its strengths and weaknesses and identifying deficiencies and suggesting solutions. We help define and prepare a comprehensive regulatory strategy. As part of the assistance services we will submit regular periodic reports on the dossier’s progress.

We can vet, asses and guide plant master files & pharmaceutical dossiers through the regulatory channels at the quickest possible speed. We closely monitor the progress of files, responding to queries and providing timely clarifications minimizing the time taken to complete the registration process.

Firmlink’s knowledge and unique experience in navigating the bewildering regulatory mazes across the pharmerging space, specifically the ASEAN zone countries has given us the expertise to register products very quickly. Our flexibility, speed and ability to execute strategic plans allow us to offer viable and innovative solutions to companies’ right through the regulatory process.

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

Our reliable and speedy regulatory assistance services ensure:

  • Dossiers meet all regulatory requirements
  • Plant Master file clearances
  • Guidance on pharmerging country regulations
  • Expert regulatory advice & push in Asean
  • Coordination of all regulatory procedures
  • Focus on marketing launch of a registered product

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