Our aim is to help your business succeed by working to streamline the pharma regulatory process.
Sciinov Group experienced regulatory consulting and FDA compliance team commands an unparalleled breadth and depth of knowledge pertaining to the FDA and EMA regulatory frameworks and can work with you to accomplish your regulatory and business objectives.
From developing and executing your regulatory strategy to obtaining NDA approval, our FDA consultants and regulatory affairs services, combined with our scientific knowledge, experience, and history of working with the FDA, enables us to advance your product quickly and successfully.
• FDA Regulatory Strategy and Gap Analysis
• FDA Meetings
• FDA Submissions
• Nonclinical Drug Development
• Chemistry, Manufacturing, and Controls (CMC) Advice and Management
• Clinical Pharmacokinetics (PK)/Pharmacodynamics (PD)
• Regulatory Due Diligence
• Pre-Approval Audits
• Specialized Regulatory Consulting Services
Email : firstname.lastname@example.org or Call : +1 (732) 526 1166
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