althian
Post-Approval Life Cycle Management
Ensure long-term regulatory compliance and market continuity with expert post-approval support.
Line Extensions & Variations
Submission and approval of new dosage forms, strengths, routes of administration, and packaging formats.
Regulatory strategy for expanding product indications or therapeutic uses.
Coordination with COFEPRIS and other LATAM agencies for timely approvals.
Renewals & Maintenance
Preparation and submission of renewal dossiers in compliance with local timelines and formats.
Monitoring of regulatory deadlines to prevent lapses in market authorization.
Support for periodic updates, including pharmacovigilance integration and safety data.
Labeling & Product Information Updates
Management of changes to SmPC, PIL, and labeling based on safety signals, regulatory feedback, or global updates.
Translation and localization of updated materials for Spanish-speaking markets.
Submission and tracking of labeling variations with health authorities.
Regulatory Change Management
Impact assessment of global regulatory changes on local registrations.
Strategic planning for implementation of updates across multiple jurisdictions.
Documentation control and version tracking to ensure audit readiness.
Regional Expertise, Global Standards
LATAM-Focused, Globally Aligned: We combine deep knowledge of regional regulations with ICH-compliant processes to support global sponsors.
COFEPRIS & LATAM Agency Liaison: Direct communication with regulatory bodies ensures faster resolution and proactive compliance.
Integrated with Pharmacovigilance & Clinical Operations: Our PALM services are seamlessly connected to safety and clinical data streams, ensuring consistency and regulatory integrity.
At Althian, we specialize in managing the full spectrum of post-marketing regulatory activities for pharmaceutical products, biologics, and medical devices. Our Post-Approval Life Cycle Management (PALM) services are designed to help sponsors, CROs, and manufacturers navigate evolving regulatory frameworks across Mexico and Latin America, ensuring that approved products remain compliant, competitive, and commercially viable.
From line extensions and renewals to safety-driven updates and labeling changes, we provide strategic oversight and hands-on execution to maintain regulatory alignment throughout the product’s lifecycle.