🇪🇨 ValiPro: ARCSA, CTD & Traceability Validation Services for Ecuador

Secure Sanitary Registration in Ecuador by Aligning Technical Dossiers with ARCSA's New CTD-based Regulations and Mandatory Traceability Requirements.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Ecuadorian market. Our documentation is built for full compliance with the rigorous standards enforced by ARCSA.

Key compliance pillars include:

• The requirement for the registration dossier to be organized in the Common Technical Document (CTD) format.

• Mandatory adherence to WHO Good Manufacturing Practice (GMP) guidelines.

• Traceability Mandates: Compliance with the Unique Traceability Code (CUT) system for all strategic medicines and health supplies.

🌟 Why ARCSA Validation is Crucial

ARCSA has recently updated its regulations (e.g., Resolution ARCSA-DE-2024-058-DASP, effective June 30, 2025), emphasizing international best practices, making detailed, structured validation data mandatory.

• CTD Submission Format: The new technical regulations for general drugs require the registration dossier to be organized into the standard CTD Modules (Module 1: Administrative, Module 2: Summaries, Module 3: Quality, Module 4: Non-Clinical, Module 5: Clinical). Process Validation Reports and Analytical Method Validation (AMV) reports are key components of Module 3 (Quality Information).

• GMP Compliance: ARCSA strictly enforces Good Manufacturing Practice (GMP) regulations, which are aligned with WHO guidelines. A valid GMP Certificate from the country of origin is required. ARCSA may conduct inspections of foreign facilities or rely on the submitted quality data (including comprehensive validation reports) to verify compliance.

• Bioequivalence (BE) Requirements: For generic products, ARCSA requires scientific and technical evidence to ensure interchangeability and biocompatibility. This often includes Bioequivalence Studies to demonstrate the generic medicine has the same pharmacokinetics and pharmacodynamics as the Reference Listed Drug (RLD). The manufacturing batch used for the BE study must be produced under validated conditions.

• Mandatory Laboratory Testing: ARCSA conducts laboratory analyses (post-registration surveillance) to verify the product's quality and accuracy relative to the data in the application. Clear, reliable, and validated analytical methods are essential for successful post-market testing.

• Traceability System (CUT): Ecuador has a mandatory traceability system (CUT) for medicines purchased by the State and prescribed in public health institutions. While this is primarily a post-manufacturing requirement, it demonstrates ARCSA's focus on end-to-end supply chain quality.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Ecuadorian market:

• CTD Compliant Exporters: Companies needing to compile and organize their quality data (Process Validation, AMV, Stability) into the required CTD Module 3 structure.

• Generic Exporters: Requiring validation documentation that supports the Bioequivalence Study and demonstrates a controlled, reproducible process.

• Post-Market Readiness: Firms needing robust Analytical Method Validation (AMV) reports that can be used by ARCSA's laboratory for verification.

🛠️ Our Process Validation Services for Ecuador

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the ARCSA submission.

ServiceEcuador / ARCSA / CTD FocusPVP & PVR PreparationProtocols and reports aligned with WHO GMP and ICH principles, suitable for submission in CTD Module 3 (section 3.2.P.3.5).Analytical Method Validation (AMV)Preparation of detailed AMV reports for all analytical methods used, to support the required Certificate of Analysis and facilitate post-market surveillance checks.CTD Module 3 Quality IntegrationExpert compilation and structuring of all quality data (Drug Substance, Drug Product, Stability, Validation) into the correct CTD format as mandated by the new regulations.Spanish Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into Spanish for submission.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by ARCSA:

• Resolution ARCSA-DE-2024-058-DASP (New General Medicines Regulation): The current mandatory technical and sanitary regulation.

• WHO GMP Guidelines: The underlying international benchmark for manufacturing practice compliance.

• CTD Format: The required structure for the registration dossier.

🤝 Get Started on Your Ecuador Validation

Ensure your process validation documentation is robust, correctly formatted to the CTD standard, and immediately acceptable to ARCSA, securing your necessary approvals and market access in Ecuador.

To receive a Technical Scope and Commercial Proposal tailored for your Ecuadorian project, simply provide:

• Product: Dosage form (e.g., solid oral, injectable, biologic) and Batch Size

• Target Status: New Sanitary Registration / Homologation (Fast-Track)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

• Existing Data: Any current validation documents or ARCSA deficiency letters.