As a Marketing Authorization Holder (MAH) or Company Representative in Mexico, we provide 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.
Key Services:
1. Regulatory Affairs and Compliance
- 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.
2. Local Representation
- 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.
3. Quality Assurance
- 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.
4. Pharmacovigilance
- 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 update reports (PSURs) as required.
5. Market Access and Distribution
- 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.
6. Digital Marketing
- 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.
7. Traditional Marketing
- 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.
8. Medical Affairs
- 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.
Benefits of Our Services:
- Expertise: Our team of regulatory, marketing, and medical affairs experts has extensive knowledge of Mexican regulations and a strong relationship with COFEPRIS.
- Efficiency: Streamlined processes and proactive management reduce time to market and regulatory approval timelines.
- Compliance: Ensuring full compliance with all local regulations, reducing the risk of non-compliance penalties and product recalls.
- Comprehensive Support: Offering a full spectrum of services from regulatory affairs to marketing and medical support, providing a one-stop solution for your market entry and growth needs.
Who Can Benefit:
- Pharmaceutical Companies: Companies seeking to register, market, and promote pharmaceutical products in Mexico.
- Medical Device Manufacturers: Manufacturers of medical devices aiming to enter and establish a presence in the Mexican market.
- Biotechnology Firms: Biotechnology firms needing regulatory and marketing support for innovative therapies and biologics.
- Nutraceutical Companies: Companies offering dietary supplements and nutraceutical products seeking regulatory approval and market presence.
Example Use Case:
Client: A multinational pharmaceutical company seeking to launch a new drug in Mexico.
- Developed a regulatory strategy tailored to the Mexican market.
- Prepared and submitted the marketing authorization application to COFEPRIS.
- Managed all communications with COFEPRIS, addressing queries and providing additional documentation as needed.
- Ensured GMP compliance for the manufacturing site.
- Established a pharmacovigilance system for monitoring and reporting adverse events.
- Supported the client during COFEPRIS audits and inspections.
- Developed a comprehensive digital marketing campaign, including social media, content marketing, and SEO.
- Organized promotional events and created marketing materials to support the product launch.
- Engaged with KOLs and provided medical education to healthcare professionals.
Outcome: The client successfully obtained marketing authorization for their new drug, launched the product on schedule, and ensured ongoing compliance with all local regulatory requirements. The integrated marketing efforts increased product visibility and acceptance among healthcare professionals and patients.
By choosing our Marketing Authorization Holder / Company Representative services in Mexico, you gain a trusted partner dedicated to navigating the regulatory landscape, ensuring compliance, and enhancing your product’s market presence through comprehensive digital, marketing, and medical affairs support.
