Company representative & Market authorization holder service
Client
A multinational pharmaceutical company seeking to launch a new drug in Mexico.
Service Provided
- 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.
To get a comprehensive strategy that ensures the success of your launch in the Mexican market, contact us.
contacto@propharmaresearch.com