Regulatory Strategy
AARIYA with a wealth of experience can help you in the decision-making process.
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Without sufficient understanding on right Regulatory strategy, many companies face delays in product registration that affect the costs. If you are unsure of your strategy, or the pros-and-cons of those you have already identified, AARIYA with a wealth of experience can help you in the decision-making process or may suggest something new through:
- Identification of reference product as per global commercialization plan and defining the regulatory pathway
- Consulting Support during product development stage
- Dealing directly with the Regulatory Agencies via. Agency Meetings, Scientific Advice, Correspondence and Protocol Assistance,
- Strategize global filings by ensuring adequate data generation in line with most recent regulatory expectations.
- Defining the appropriate regulatory pathway when regional complexities are present (e.g. EU – National Procedure, De-Centralized Procedure (DCP), Mutually Recognized Procedure (MRP)]
- Due diligence for extending products approved in one region to other markets
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.
