Regulatory Services in Mexico
Regulatory Services
- Global presence regarding medicines, medical devices
- Regulation requirements for market manufacturers and obtaining the regulatory approvals
- Challenges faced
- How DDReg can help/DDReg services
Mexico
Mexico is the second largest market for medicinal products and devices in Latin America. It is an emerging candidate regarding biologic drug regulation in the region and creates ample opportunities for the Mexican Medical Device market. While Mexico’s regulatory body Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS, oversees regulation activities in the country the process for submission is time costly leading to a backlog of submissions.
As a leading global contender, DDReg’s Regulatory Services in Mexico provides on-going support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filing and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management
- QPPV Services
- Bio Waiver Justifications
- Clinical & Non-Clinical Expert Reports
- IPR Support including Worldwide Patent Status and Patent Reviews