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