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Development, Design and Prototype Stage
Pre-clinical and Clinical Development
Regulatory Clearance and Approval
Postmarket Activities
In order to gain product regulatory clearance or approval, you will need to meet specific criteria set forth by all of the appropriate regulatory bodies. You will also need to preserve the integrity of your manufacturing process as you scale up for production. Synergia Bio Sciences can prepare you and your facilities for possible regulatory audits and Notified Body assessments.

Synergia Bio Sciences will consider the current regulatory environment, relevant guidelines, and ongoing local and / or international initiatives that could influence your regulatory pathway. Our goal is to facilitate a cost effective, competitive, and successful product clearance or approval in the shortest time possible. Our regulatory experts and project managers are well respected by the Central Drugs Standard Control Organisation (CDSCO) and other regulatory agencies. Synergia staff has excellent rapport with agency leaders and reviewers, earned through years of professional experience and regular interactions.

Our goal is to provide you with a clear understanding of the types of regulatory and clinical trial requirements you will encounter as you work towards launching your product in India and internationally. We will define a strategy that will move your product along the appropriate pathway more easily and reduce the cost and time to bring your innovation from the bench to the beneficiary - and meet your ultimate goal of bringing safe and effective medicines and medical technology where it is needed, to the patient. We will ensure that all product development activities undertaken in India are in synch with regulatory requirements of the US FDA or EMA as per your requirement.

For clients based outside of Europe, Synergia Bio Sciences can service as your European Authorized Representative
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