Regulatory Affairs Services
End-to-End Regulatory Strategy, Submissions & Lifecycle Management
Get Free Regulatory ConsultationRegulatory Affairs is the foundation of successful market entry and long-term compliance. At Medwisdom, we deliver strategic, compliant, and globally aligned regulatory solutions that help your products achieve faster approvals with minimal regulatory risk.
Our Regulatory Affairs Capabilities
Complete regulatory support from early strategy to post-approval lifecycle management
1. Regulatory Strategy & Product Classification
- Product classification & regulatory pathway
- Country-specific submission strategy
- Gap analysis of technical documentation
- Risk identification & mitigation planning
2. Dossier Development & Compilation
- CTD / eCTD / ACTD dossier preparation
- Modules 1–5 compilation
- CMC, quality, safety & efficacy documentation
- ICH-aligned stability & GMP documentation
3. Registration & Authority Submissions
- Online regulatory submissions
- Agency query & deficiency management
- Scientific justification & responses
- Coordination of GMP inspections
4. Post-Approval Lifecycle Management
- Minor & major variations
- Labeling, artwork & SmPC updates
- Shelf-life extensions
- Renewals & re-registrations
5. Manufacturing & Quality Changes
- Change of site or manufacturer
- Process & formulation changes
- API / DMF assessment & alignment
6. Market Expansion & Regulatory Intelligence
- Multi-country registration support
- GCC & global regulatory harmonization
- Regulatory intelligence & compliance monitoring
Global Regulatory Standards We Follow
Our regulatory strategies are built on internationally recognized guidelines
ICH Guidelines
CTD/eCTD, quality, safety & efficacy standards
WHO Guidance
Global regulatory systems & compliance
EMA Regulatory Framework
EU scientific & variation requirements
U.S. FDA Guidance
US regulatory, quality & submission standards
Why Choose Medwisdom for Regulatory Affairs?
Strategic, compliant, and approval-focused regulatory solutions
Global Regulatory Expertise
Experience across EU, US, GCC, Asia & Africa
End-to-End Regulatory Ownership
From strategy to post-approval management
Strong Scientific & CMC Expertise
Robust, approval-ready dossiers
Faster Approvals
Speed-focused strategies with fewer queries
Multi-Category Support
Pharma, biologics, devices & cosmetics
Transparent Project Management
Clear timelines, updates & accountability
Ready to Accelerate Your Regulatory Approvals?
Let our regulatory experts manage your submissions and compliance — accurately, efficiently, and globally.
Book Free Regulatory Consultation