Regulatory Services in Mexico
Regulatory Compliance Experts in 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 devices 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.
Why Choose DDReg for Regulatory Services in mexico
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.
Our Regulatory Consulting Services In Mexico Portfolio Covers
- Regulatory Strategies and Expert Views
- Regultory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
Our Regulatory Affairs Consulting Services in Mexico portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
