althian
Regulatory Intelligence & Gap Analysis
Anticipate regulatory challenges before they impact your clinical trial. At Althian, we offer proactive monitoring of regional regulations, technical guidelines, and compliance frameworks to ensure your clinical research documentation is fully aligned with local and international standards. Our team specializes in identifying potential risks, inconsistencies, or gaps in regulatory dossiers before submission—helping sponsors, CROs, and pharmaceutical companies avoid costly delays and rejections.
Continuous Regulatory Surveillance: We track updates from key health authorities such as COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), and others across Latin America to keep your strategy current and compliant.
Documentation Gap Analysis: Our experts review protocols, investigator brochures, informed consent forms, and submission packages to detect missing elements, outdated references, or non-compliant content.
Pre-Submission Readiness Audits: We conduct thorough evaluations to ensure your documentation meets all country-specific requirements, reducing the risk of regulatory setbacks.
Strategic Advisory & Alerts: Receive timely insights and recommendations when regulatory changes may affect your study design, approval pathway, or documentation strategy.
Multi-Country Harmonization Support: For regional trials, we help align documentation across LATAM markets to streamline submissions and reduce duplication.
Regulatory monitoring Mexico, COFEPRIS compliance consulting, clinical trial documentation review LATAM, regulatory gap analysis Latin America, pre-submission audit CRO, health authority guidelines Mexico, regulatory risk assessment for clinical trials, pharmaceutical regulatory strategy LATAM.
Based in Mexico, Focused on LATAM: Our regional presence gives us direct access to evolving regulations and local expectations.
Expertise Across Therapeutic Areas: We support studies in oncology, infectious diseases, CNS, and more—adapting regulatory strategies to each indication.
Trusted by Global Sponsors and CROs: Our clients rely on us to navigate complex regulatory environments with precision and agility.