Synowledge can provide assistance throughout the development, approval, and post-approval stages of a product’s lifetime. Our consulting and support services include detailed compliance assessments and audits, analysis of regulatory hurdles/roadblocks and opportunities, as well as quality assurance and quality control support. Our team at Synowledge can help you by reducing review time, ensuring the required quality to achieve quick regulatory approvals and meet global regulatory standards.
Global regulatory and safety strategy development review and assessment
Quality and Regulatory Compliance audits and training
Identification, Inspection and due diligence Reviewing and assessing clinical and BE study protocols
CMC, non-clinical, clinical data review
Liaison services with global regulatory agencies
Translation of technical documents Dossier Management