Regulatory Submissions (eCTD), Quality & Compliance (DEL) for Start-up MAH

Client Type: Biologics, Pharmaceuticals, Medical Devices, Business Development

Jurisdiction(s): Canada

Services Provided: Strategic and business development advice. Assessment of technical & quality documentation of products in scope to prepare for regulatory submissions for Health Canada for priority approval. Development and execution of regulatory strategy. Prepared detailed QMS procedures based on products. Prepared for and hosted internal and Health Canada GMP audits. Provided GMP and SOP training. Prepared a DEL for import/distribution and amendments and submitted required evidence for GMP compliance. Coordinated import testing and GMP implementation.