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 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 environment 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 cosmetic 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
As a USFDA Warning Letter Remediation Specialist, MIVADO GlobalPerformance helps life science companies address significant cGMP violations, ensuring a compliant, timely (within 15 business days), and accepted response to the FDA. Our Consultants develop CAPA (Corrective and Preventive Action) plans, conduct root cause analyses, and create evidence-based proof books to prevent further enforcement actions like consent decrees or product seizures.
Awards & Certifications
