Post-Approval
Lifecycle Management
Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than Aariya.
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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