Regulatory Affairs Services from Mivado GlobalPerformance guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, combination products, and other natural Health products for all stages of development.
We are a team of experienced regulatory professionals in the Canadian regulatory environments who advise and provide regulatory support for products in all stages of development (preclinical to post-market).
We provide regulatory assessment, strategy, and guidance for the Canadian market, building scalable project models that meet your unique needs and budgets.
Regulatory Strategy and Operation
- Gap Analysis and Classification
- Lifecycle Management
- Drug establishment licensing,
- NHP Site Licensing and product release
- Maintain compliance at any stage of the product lifecycle
- Regulatory monitoring
Biopharma and Medical Devices
- DIN, NPN and DMF Application preparation and filing
- New drug and biologic submissions
(NDS, SNDS, ANDS) - Prescription (Rx) to over-the-counter (OTC)
switch submissions - Medical device license applications
Foods, Cosmetics and Natural Health Products
- Natural Health Product (NHP) and food submissions
- Cosmetics and new substance notifications
- Evaluating the acceptability of natural health products and cosmetics formulations
- New Product Approval and Label evaluation
Business and Market Access
- Registration and regulatory monitoring with health authorities
- Obtaining and renewing marketing authorizations
- Pharmacovigilance
- Preparation of the reimbursement and price definition monitoring
- Compliance and monitoring of implemented procedures
