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Regulatory Affairs
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Let Us Guide You!
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Bringing new products from development through the approval process, is an expensive and lengthy process.
If unanticipated delays occur, costs in both time and dollars can rapidly escalate.
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Whether your new product is a drug, a biologic, a device or a combination, our experienced people are ready to work with you to set
and help deliver on aggressive timelines that control costs.
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The regulatory expertise at Synteract can benefit your project during all phases of development, whether it is preparing the IND or IDE
to facilitate the first studies in humans or preparing an application [Marketing Authorization Application (MAA), New Drug Application (NDA),
Pre-Market Approval (PMA) and 510k] for review by regulatory authorities.
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Synteract also has extensive post-marketing experience. Once your product is approved, Synteract assists with safety
surveillance [including the expedited reporting of serious adverse events (SAEs)], periodic reporting, designing and implementing
phase 4 studies, preparing supplemental NDAs, drafting standard responses and medical information letters, preparation of manuscripts, etc.
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Regulatory Affairs Services
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- Regulatory strategy
- Preparation of IND, IDE, MAA, NDA, PMA, 510k
- Representation with regulatory authorities, including FDA
- Preparation for regulatory meetings
- Charter and interface with Data Safety Monitoring Boards, Advisory Panels
- GMP, GCP training and auditing
- Designing and implementing a compliant quality system
- Preparation of SOPs
- IRB and Ethics committee approvals
- Due diligence
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