Compliance Solutions

Sensyo has the unique ability to provide cGMP compliance auditing and training, FDA pre-approval inspection assistance, validation of manufacturing processes, qualification of computerized information systems, MES evaluation and implementation, documentation review, interpret regulations, develop regulatory strategies and compliance requirements, perform third-party GAP audits and write and review submissions.

Our regulatory submission services also include:

• Clinical Trial Applications (CTA)
• Common Technical Document (CTD)
• Special Access Program
• DIN Submissions
• New Drug Submissions (NDS)
• Abbreviated Submissions (ANDS)
• Appeals
• Electronic Submissions
• Roadmaps of Current Submission Types to CTD/CTA