Introduction

In the bio-pharma industry, co-marketing is a powerful strategy that allows companies to jointly promote a pharmaceutical product or health solution, often accelerating market penetration and maximizing return on investment. However, while co-marketing can enhance brand credibility and broaden reach, it is not without regulatory challenges, especially in highly regulated regions such as Mexico, Brazil, and LATAM.

Each country within Latin America presents a unique regulatory landscape that affects how co-marketing campaigns can be structured, executed, and monitored. From differences in drug approval processes to advertising restrictions and compliance mandates, navigating this complex environment is critical for success.

In this article, we explore the regulatory challenges of co-marketing in the pharmaceutical sector, provide real-world examples, and showcase how PRO PHARMA RESEARCH ORGANIZATION can support your co-marketing initiatives with a wide range of strategic services.

Understanding the Regulatory Landscape in LATAM

Country-Specific Regulatory Bodies

In Mexico, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) oversees drug approval, advertising regulations, and medical communications. In Brazil, ANVISA (Agência Nacional de Vigilância Sanitária) plays a similar role. Other LATAM countries have their own health authorities with varying levels of enforcement and documentation requirements.

These regulatory agencies impose strict guidelines on:

• Promotional content
• Labeling and packaging
• Claims made in advertising
• Interactions with healthcare professionals (HCPs)

Key Co-Marketing Regulatory Challenges

⏳ Approval Delays

Even if a product is approved in one LATAM country, it does not guarantee fast-track approval in another. Regulatory approval can take 6 to 18 months, affecting co-marketing timelines.

⚖️ Advertising Compliance

In many LATAM countries, direct-to-consumer (DTC) advertising for prescription drugs is prohibited. Even HCP-focused campaigns must be educational in nature, limiting co-marketing creativity.

📊 Data Sharing and Privacy

The exchange of customer or patient data between partners must comply with data protection laws such as Brazil’s LGPD or Mexico’s Federal Law on Protection of Personal Data Held by Private Parties.

💼 Unequal Responsibilities

Pharma companies must clarify who is responsible for:

• Pharmacovigilance
• Product complaints
• Regulatory submissions

Unclear delegation can lead to non-compliance fines.

Examples of Regulatory Challenges and Solutions 

Example 1: Co-Branded Webinar in Brazil

A multinational company partnered with a local firm in Brazil to conduct an educational webinar targeting cardiologists. Despite having top-tier speakers and medical insights, the promotional materials were flagged by ANVISA due to unsubstantiated product claims.

Solution: They engaged a local regulatory affairs partner who helped rewrite the content to align with educational guidelines, shifting the webinar toward disease awareness and treatment pathways.

Example 2: Joint Product Launch in Mexico

Two pharmaceutical companies launched a cardiovascular drug in Mexico under a co-marketing agreement. However, the COFEPRIS review delayed approval because both brands submitted separate dossiers, creating inconsistency in documentation.

Solution: They adopted a unified regulatory strategy and hired a joint consultant to standardize the labeling, pharmacological data, and marketing materials.

Example 3: Digital Campaign in LATAM

A digital ad campaign launched in Argentina and Chile aimed at physicians was halted mid-way because the content mentioned superiority claims without supporting clinical evidence.

Solution: The companies revised their shared digital marketing campaign to focus on real-world evidence and guideline-based recommendations, approved by both local regulators.

Best Practices for Regulatory Compliance in Pharma Co-Marketing

• Joint Regulatory Planning: Establish a co-marketing regulatory steering committee with representatives from both partners to oversee compliance efforts from the start.
• Pre-Approval of All Materials: All co-branded materials—brochures, websites, webinars, videos—should be submitted for pre-approval to local authorities wherever required.
• Aligned Pharmacovigilance Plans: Clearly assign roles for adverse event reporting, ensure that both parties maintain harmonized safety data collection protocols.
• Consistent Messaging: Craft messages that are both scientifically valid and regulatory-compliant across all platforms and channels.
• Cultural and Language Adaptation: Translate not just the language but the context of marketing materials, adapting to local cultural and clinical practices.

How Pro Pharma Research Organization Supports Co-Marketing for Bio-Pharma in Mexico, Brazil and LATAM?

Navigating regulatory challenges in pharma co-marketing doesn’t have to be a roadblock. At PRO PHARMA RESEARCH ORGANIZATION, we provide end-to-end support tailored to bio-pharma companies operating in Mexico, Brazil, and LATAM.

Our co-marketing services include:

• Webinars and Educational Events
• Collaborative Content Creation (White Papers, Case Studies, and Research Reports)
• Shared Digital Marketing Campaigns
• Co-Hosted Product Launches and Demonstrations
• Mutual Lead Sharing and Referral Networks
• Collaborative Social Media Campaigns
• Joint Participation in Conferences and Industry Events
• Co-Marketing on Patient and Professional Education Programs
• And more

Our deep expertise in regional regulations, combined with our multidisciplinary teams in regulatory affairs, medical writing, digital marketing, and scientific communication, allows us to mitigate risk and maximize impact.

Contact us for more information and get access to our services about co-marketing in LATAM.

Conclusion

While co-marketing in the pharmaceutical sector presents significant growth opportunities, it also brings with it a series of complex regulatory hurdles—especially in diverse regions like Mexico, Brazil, and LATAM. Failing to consider regulatory nuances can derail even the most promising collaborations.

But with the right strategy, planning, and support, companies can overcome these barriers. Leveraging expert partners like PRO PHARMA RESEARCH ORGANIZATION, pharma firms can confidently launch compliant, impactful co-marketing campaigns that expand reach and improve patient outcomes.

Whether it’s through joint educational programs, co-hosted events, or shared digital initiatives, the future of bio-pharma growth in LATAM lies in collaborative, regulation-savvy co-marketing.