Why US?

“We guide our customers through the complete regulatory process, right from dossier preparation to filing to final approval.” At API First we try to provide solution to all your concerns viz. strategizing, product selection, product development, dossier preparation, filing, liasoning, query responses, customer identification, registration holder and what not. We do not rely on publicity to gain access to clients, rather our work speaks for itself. We rely on customer satisfaction, our success rates, ethics, transparency, client’s feedback.

  • We guide or customers through the complete regulatory process, right from dossier preparation to filing to final approval.
  • We help our clients with product selection by providing the market data relevant to the product in question. This provides an insight and makes decision making easy for client to decide whether to move ahead or drop the project or may come up with modifications.
  • With a 100% success rate, we can be relied upon to handle your project with utmost sincerity.
  • We support our customers in preparing replies for the concerns raised by the authority on the CMC, clinical, non-clinical, administrative or any other issue.
  • We do not deliver on time; we actually deliver before time. With a strong team of experts, dedicated associates, we leave no stone unturned to get the projects approved before time.
  • Our support team aids in post marketing activities viz PSUR filing, PI updates, applicability of updated rules and guidelines on approved products etc.
  • Variation/ Post approval changes filing and their approval.
  • We upfront provide the checklist for various applications so that the client be better prepared beforehand. This helps to prepare the error free documentation and aids in expediting the filing process.
  • For new manufacturing set-ups we provide layouts meeting all the applicable GMP requires of USFDA, EU, PIC/s, WHO etc. We also help our clients to identify the right civil contractors, AHU suppliers, Water system suppliers etc.
  • We provide transparent guidance on the product and process related queries. We provide the complete pathway to our clients with probable timelines at each step, so an informed decision can be taken.
  • We support our client to identify the best service providers for all the allied services such as Clinical Research Organizations (CRO’s), Labs for non-clinical studies, RM suppliers etc. We only work with Govt. approved suppliers but also ensure that they are the ones with highest credibility and data generated is authentic and error free.
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API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.

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apifirstreg@gmail.com apifirstblog@gmail.com
+917814218338
Plot No. 152, First Floor
Industrial Area
Phase 2
Panchkula , Haryana 134113
India