Global Regulatory
Submissions
Submissions
Regulatory expertise. Global market access.
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Dr. Winston Costa Pereira
CEO and Chief Regulatory Specialist
Practical regulatory support for your products and international markets.
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[email protected]www.regulatoryaffairs.caWhy choose Global Regulatory Submissions?
- One coordinated regulatory partner. Connect export documentation, SDS, drug submissions, medical-device licensing and cosmetic compliance within one service portfolio.
- A structured export program. Certificate of Free Sale support covers document review, package preparation and coordination of apostille or authentication and legalization for your destination.
- Clear export timelines. Our export program offers a five-business-day apostille service for eligible documents and applicable Hague destinations, starting when complete, acceptable documents are received. Embassy legalization timing depends on the authority.
- Hands-on document support. We prepare, organize and review submission materials, labels, SDS and supporting records, with attention to completeness and consistency.
- Direct senior guidance. Discuss your pathway, priorities and documentation needs directly with our senior regulatory specialist through structured consultations.
- Practical scope and communication. Clear deliverables, destination-specific requirements and explained fees and timelines help you plan the work and make informed market-entry decisions.
EXPLORE OUR SERVICES
Export
- Certificates of Free Sale and export documentation support
- Destination-market requirements and document preparation
- Support for international market access
SDS — Safety Data Sheets
- GHS-aligned Safety Data Sheet authoring
- Review and updates to existing SDS documents
- Hazard communication and labelling support
Drugs
- Regulatory strategy and submission planning
- Preparation and management of submission documents
- Compliance reviews and regulatory correspondence support
Medical Devices
- Regulatory pathway and licensing support
- Technical documentation and submission preparation
- Compliance review and market-access guidance
Cosmetics
- Product classification and market-entry guidance
- Ingredient and label compliance review
- Cosmetic notification and documentation support