Company representative and Marketing authorization holder services in Mexico
Your trusted partner for regulatory compliance, market access, and comprehensive marketing support in Mexico
As a Marketing Authorization Holder (MAH) or Company Representative in Mexico, Pro Pharma Research Organization provides comprehensive regulatory and compliance services to ensure your pharmaceutical, medical device, or health-related products meet all necessary legal and regulatory requirements for marketing and distribution in Mexico.
Additionally, we offer digital marketing, traditional marketing, and medical affairs support to enhance your product’s market presence and ensure compliance with medical standards. Our expert team navigates the complexities of local regulations, enabling you to focus on your core business operations while we handle the essential regulatory and marketing aspects.
Service overview
Regulatory Submissions
Preparation, submission, and management of marketing authorization applications, ensuring compliance with COFEPRIS (Federal Commission for the Protection against Sanitary Risk) requirements.
Regulatory Strategy
Development of regulatory strategies tailored to your product type and market goals, minimizing approval time and ensuring regulatory compliance.
Post-Approval Maintenance
Management of post-approval regulatory obligations, including renewals, variations, and amendments to marketing authorizations.
Legal Representation
Acting as the official representative of your company in Mexico, liaising with local authorities, including COFEPRIS.
Communication
Managing all communications with regulatory bodies, ensuring timely responses and effective resolution of any regulatory issues.
Document Handling
Handling and storing all regulatory documentation in compliance with local laws.
GMP Compliance
Ensuring Good Manufacturing Practice (GMP) compliance for all manufacturing sites and processes.
Quality Control
Overseeing quality control processes to maintain product integrity and compliance with local standards.
Audits and Inspections
Coordinating and supporting regulatory audits and inspections by COFEPRIS or other relevant authorities.
Adverse Event Reporting
Establishing and maintaining a robust pharmacovigilance system to monitor and report adverse events.
Risk Management
Developing and implementing risk management plans to ensure product safety.
Safety Updates
Preparing and submitting periodic safety reports (PSRs) as required.
Market Research
Conducting market research to identify regulatory pathways and potential obstacles for your product.
Distribution Support
Assisting with the logistics of product distribution, including import/export regulations and local distribution requirements.
Product Launch
Supporting product launch activities, ensuring compliance with marketing and promotional regulations.
Social Media Management
Creating and managing social media campaigns to engage with healthcare professionals and patients.
Content Marketing
Developing and distributing educational and promotional content through blogs, videos, and infographics.
SEO/SEM
Optimizing your digital presence for search engines to increase visibility and drive traffic to your website.
Email Marketing
Designing and executing email campaigns to inform and engage your target audience.
Advertising
Developing and placing advertisements in relevant medical journals, magazines, and online platforms.
Events and Conferences
Organizing and representing your company at industry events, conferences, and trade shows.
Promotional Materials
Creating brochures, flyers, and other marketing materials to support sales efforts.
Medical Education
Providing training and education for healthcare professionals on your product’s benefits, usage, and safety.
Key Opinion Leader (KOL) Engagement
Building relationships with KOLs to advocate for your product and provide expert insights.
Clinical Support
Assisting with clinical trials, including regulatory submissions, site selection, and monitoring.
Medical Information
Managing inquiries from healthcare professionals and patients, providing accurate and compliant information.
Our services deliver expert guidance on Mexican regulations, streamline approval processes, and ensure compliance to mitigate risks. We offer comprehensive support across regulatory, marketing, and medical affairs for pharmaceutical, medical device, biotechnology, nutraceutical, consumer health, and cosmetics companies. Partnering with Pro Pharma Research Organization means a trusted ally to navigate regulations, secure approvals, and enhance market presence.
