Streamline your regulatory submissions with precision, compliance, and regional expertise. 

Althian provides end-to-end support for the preparation and submission of regulatory dossiers in CTD and eCTD formats, tailored to the specific requirements of health authorities in Mexico, Brazil, and across Latin America. Our services are designed to ensure technical accuracy, regulatory compliance, and strategic alignment with your product’s market entry goals.

CTD/eCTD Compilation & Formatting:

• Structuring all five modules (Administrative, Summaries, Quality, Nonclinical, Clinical) according to ICH guidelines and local adaptations.

• Formatting documents with precise metadata, bookmarks, and hyperlinks to meet electronic submission standards.

• Harmonizing content across multiple jurisdictions to support simultaneous submissions in LATAM.

Scientific & Regulatory Content Review:

• Reviewing clinical, nonclinical, and quality documentation to ensure consistency, clarity, and regulatory alignment.

• Identifying gaps or inconsistencies that could delay approval and recommending corrective actions.

• Translating and adapting technical content for bilingual submissions (English–Spanish/Portuguese), ensuring linguistic precision and regulatory relevance.

Technical Validation & Submission Readiness:

• Performing rigorous validation checks using industry-standard tools to ensure eCTD structure integrity.

• Preparing submission packages compatible with COFEPRIS, ANVISA, INVIMA, and other regional platforms.

• Managing version control and document lifecycle to maintain traceability and compliance.

Submission Strategy & Regulatory Liaison:

• Developing tailored submission timelines based on agency responsiveness and product classification.

• Coordinating directly with regulatory authorities to clarify requirements and expedite review.

• Supporting pre-submission meetings and post-submission follow-ups to ensure smooth communication and issue resolution.

Lifecycle Management & Post-Approval Updates:

• Handling variations, renewals, and safety updates with full documentation and regulatory tracking.

• Maintaining dossier integrity across updates, ensuring consistency with initial submissions.

• Supporting pharmacovigilance-related amendments and compliance reporting.

Regional Expertise & Multinational Coordination:

• Navigating the regulatory landscapes of Mexico, Brazil, Colombia, Argentina, and other LATAM markets.
• Aligning dossier strategies with global regulatory pathways (FDA, EMA) for sponsors seeking multi-region approvals.
• Offering scalable solutions for biotech startups, mid-size pharma, and global CROs entering Latin America.