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Development, Design and Prototype Stage
Pre-clinical and Clinical Development
Regulatory Clearance and Approval
Postmarket Activities
You have a great idea for a new product. Perhaps you completed an initial business plan, defined the market for your product, identified performance specifications, and are refining clinical uses based on your core technology and the results of bench and animal testing.

Many of the decisions you make now can have tremendous impact on the success of your project. By anticipating the regulatory and clinical trial requirements associated with your new product now, you can address questions that will improve its chances of successfully being approved or cleared.

Synergia Bio Sciences can help you with your product development strategy by identifying a product-specific regulatory strategy for India and other global markets.

Specifically, we can help you to:

Assess the impact of the regulatory environment
Assess applicable regulations and specific country requirements
Determine product classification and essential requirements
Design and review your pre-clinical test plans and clinical studies
Review and evaluate your technical and clinical data, including labelling reviews and risk management determinations
Help you to begin a collaborative dialog with regulatory agencies through formal or informal communications
Serve as your liaison with Notified Bodies and Competent Authorities
Define and assess your product labelling claims and associated clinical data requirements
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