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)

Vision

To become a noble regulatory consultancy, delivering high quality regulatory support to clients for introduction of wide range of generic and branded products in the market.

Mission

We thrive to provide quality focused and flexible services to the utmost satisfaction of our clients building long-term relationship.

Values

Success and strength of any company rests on its strong beliefs and values. We believe in Customer service excellence, Uncompromising quality, Ethics and integrity

Our Client’s Testimonials

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