HA Queries - Responses
Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than Aariya.
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Health Authority (HA) Queries - Responses
AARIYA has a proven track record in handling HA queries for speedy approval and uninterrupted commercialization of a product through:
- Prompt resolution of deficiencies to rescind Refuse-to-Receive (RTR) decision
- Swift addressal of Easily Correctable Deficiencies (ECDs), Information Requests (IRs), Discipline Review (DR) letters, Screening Deficiency Notices (SDNs), CMC/ BE, Clarifax(es), CMS/ RMS comments, etc. without impacting the review clock
- Requesting scientific advice from the HAs for action on Complete Response Letters (CRLs) and Notices of Non-Compliance (NONs)