althian
Clinical Trial Applications (CTA) & Approvals
Accelerate your clinical research with expert regulatory support for CTA submissions. At Althian, we specialize in the preparation, submission, and follow-up of Clinical Trial Applications (CTAs) to secure timely and compliant approvals for conducting clinical trials in Mexico and across Latin America. Our regulatory team ensures that every component—from protocols and investigator brochures to informed consent forms—is meticulously crafted to meet the specific requirements of local health authorities such as COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), and others.
Whether you’re a global sponsor, CRO, or pharmaceutical company, we help you navigate the complex regulatory landscape to initiate clinical trials efficiently and ethically.
Strategic CTA Planning & Dossier Assembly
Development of tailored CTA strategies based on study phase, therapeutic area, and country-specific requirements.
Compilation of complete submission packages, including study protocols, investigator brochures (IBs), informed consent forms (ICFs), and supporting documentation.
Alignment with ICH-GCP standards and local regulatory frameworks (e.g., COFEPRIS in Mexico, ANVISA in Brazil, INVIMA in Colombia).
Document Review, Translation & Localization
Technical and regulatory review of all CTA components to ensure clarity, consistency, and compliance.
Professional translation and localization of trial documents for Spanish- and Portuguese-speaking markets, with attention to cultural nuances and legal terminology.
Adaptation of ICFs to meet local ethics committee expectations and patient protection laws.
Submission Coordination & Regulatory Liaison
Direct engagement with health authorities and ethics committees to facilitate smooth submission and approval processes.
Management of timelines, submission windows, and regulatory correspondence to avoid delays.
Proactive resolution of queries, deficiencies, and clarifications during the review cycle.
Approval Tracking & Post-Submission Support
Real-time monitoring of application status and feedback from regulatory bodies.
Strategic follow-up to ensure timely approvals and readiness for site activation.
Support for amendments, protocol updates, and re-submissions when required.
Multi-Country Trial Enablement
Harmonization of CTA documentation for multicenter and multi-country studies across Latin America.
Advisory on regulatory differences, submission formats, and approval timelines in each target market.
Centralized coordination for sponsors conducting regional trials with multiple CROs or sites.
At Althian, we provide full-spectrum support for Clinical Trial Applications (CTAs), ensuring your study is approved efficiently, ethically, and in full compliance with local and international regulations. Our CTA management services are designed to reduce regulatory friction, accelerate trial startup, and safeguard the integrity of your research from day one.