althian
Regulatory Strategy & Consulting
Tailored Regulatory Roadmaps: Strategic planning for each phase of your submission process, adapted to local regulations in Mexico, Brazil, Colombia, Argentina, and other LATAM markets.
Regulatory Intelligence & Gap Analysis: In-depth assessments of current regulations, submission pathways, and documentation requirements to identify risks and opportunities.
Agency Liaison & Submission Support: Direct engagement with COFEPRIS and other regional health authorities to streamline communication and accelerate timelines.
Compliance & Documentation Review: Expert guidance on dossier preparation, labeling, pharmacovigilance plans, and clinical trial applications.
Market Entry Strategy: Regulatory planning aligned with commercial goals to ensure smooth product launch and post-approval compliance.
Navigate complex regulatory landscapes with confidence. At Althian, we specialize in the development of customized regulatory strategies for drug, biologic, and medical device submissions across Mexico and Latin America. Our consulting services are designed to help pharmaceutical companies, CROs, and biotech innovators achieve successful approvals by aligning with country-specific regulatory requirements and international standards.