New Market Authorizations - API

Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than Aariya.

WE CAN HELP...!



MEET US



DISCUSS WITH US



GET SOLUTION

New Market Authorizations – API

With a proven expertise in handling all types of API (chemical/ fermentation/ sterile/ biologicals), Excipient and Pre-mix master-file submissions to global health authorities, AARIYA is one of preferred Regulatory partner across the globe in regulatory writing, review and compilation of:

  • Drug Master Files (DMFs)
  • Active Substance Master Files (ASMFs)
  • Certificates of Suitability (CEPs)


Our Client’s Testimonials

    Manager-Regulatory AffairsHead of Regulatory Affairs
  • Aariya’s seamless support in arranging quality labeling, technical inputs, quality review, and most importantly their short turn-around time helped us in timely response to the FDA thereby assisting in securing faster product approval.
    Manager-Regulatory Affairs
    A Malaysian Based Generic Pharmaceutical Company
  • They are great with their prices and excellent with their turn-around times. The most important quality that I like about Sachin and his team is that they would go that extra mile to get the job done and have so far never let us down.
    Head of Regulatory Affairs
    A US Based Generic Pharmaceutical start-up