Post-Approval
Lifecycle Management

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

Post-Approval Life-cycle Management

AARIYA understands the pivotal role post-approval activities play in the product life-cycle maintenance of a product, and has the Regulatory expertise to ensure your product licenses are maintained as correct, current, valid and safe, through:
  • Evaluation of proposed change, regulatory assessment of submission category and identification of required supporting documents
  • Compilation and submission of post-approval submissions:
    • Line extension
    • Commitment to Conditional Approval
    • Supplements (PAS, CBE-30, CBE-0) and Variations (Type I & II)
    • Annual Reports and Annual Notifications
    • Renewals and Re-registrations
    • PV Compliance

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