🇻🇪 ValiPro: SACS/INHRR, CTD & GMP Process Validation Services for Venezuela

Secure Market Authorization in Venezuela by Navigating the Intricate SACS/INHRR Requirements and Ensuring Flawless Technical Dossier Submission.

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

Key compliance pillars include:

• CTD Submission Format: Dossiers are typically structured in the Common Technical Document (CTD) format (Modules 1-5).

• GMP Compliance: Mandatory submission of Good Manufacturing Practice (GMP) Certificates for both the Finished Product and the Active Pharmaceutical Ingredient (API) manufacturer.

• Apostille and Legalization: Strict requirements for legalization, translation, and apostille of all documents issued abroad.

• Detailed Quality Information: The quality module must contain extensive details on the drug substance and drug product, supported by validated data.

🌟 Why SACS/INHRR Validation is Crucial

The complexity and shifting nature of Venezuela's regulatory landscape necessitate a highly accurate and legally compliant dossier supported by robust validation data to minimize delays and prevent rejection.

• CTD Module 3 Quality: The registration dossier requires the presentation of technical information in the CTD format. Your Process Validation Reports and Analytical Method Validation (AMV) reports are the core components of Module 3 (Quality Information). This module must include:

  • Drug Substance Details: Supported by the API manufacturer's GMP certificate.

  • Drug Product Manufacturing: Process description, process control, and validation reports (Process and Cleaning Validation).

• Mandatory GMP for APIs and FPPs: As of July 2023, it became mandatory to submit a copy of the GMP Certificate(s) of the manufacturer(s) of the Active Pharmaceutical Ingredient (API) at the time of application to the INHRR, in addition to the Finished Product GMP certificate. Your validation documentation must align with the GMP principles of the issuing authority (usually WHO/ICH standards).

• Legalization and Translation: All foreign-issued documents, including GMP certificates and possibly validation summaries, must be authenticated (apostilled) and officially translated into Spanish. This emphasizes the need for legally sound and complete underlying technical reports.

• Sample Analysis: SACS and INHRR have the authority to request samples for analysis by the competent authorities to ensure quality control, making the submission of validated analytical methodology and robust finished product specifications critical for successful verification.

• Interchangeability/Bioequivalence: The authorization process for generic and brand-name products is generally the same, but the required documentation varies. Generic submissions must include evidence of efficacy and safety, often necessitating Bioequivalence Studies supported by documentation of the manufacturing process of the biobatch.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Venezuelan 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 any required Bioequivalence Study and demonstrates a controlled, reproducible process.

• Legalization Support: Firms needing to ensure their technical summaries are accurately and legally prepared for apostille and official translation.

• API GMP Compliance: Companies requiring documentation that supports the required API GMP Certificate.

🛠️ Our Process Validation Services for Venezuela

We provide complete, scientifically sound, and document-intensive support tailored to the content and legal requirements of the SACS/INHRR submission.

ServiceVenezuela / SACS/INHRR / GMP FocusPVP & PVR PreparationProtocols and reports aligned with ICH/WHO GMP principles, documenting manufacturing and cleaning processes, 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, supporting the Certificate of Analysis and facilitating any INHRR/SACS testing.Quality Dossier IntegrationExpert compilation and structuring of all quality data (including validation summaries) into the correct CTD Module 3 format for the SACS submission.Spanish Translation ReadinessEnsuring technical documents are clear, concise, and structured appropriately to facilitate accurate official translation and legalization (apostille).

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by SACS/INHRR:

• Ley Orgánica de Salud (1998): The main health legal framework.

• GMP Regulations: National and internationally recognized (WHO/ICH) guidelines for manufacturing practice.

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

🤝 Get Started on Your Venezuela Validation

Ensure your process validation documentation is robust, correctly formatted to the CTD standard, and prepared for the strict legal requirements (apostille/translation), securing your necessary approvals and market access in Venezuela.

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

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

• Target Status: New Sanitary Registration / Renewal

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

• Existing Data: Any current validation documents or SACS/INHRR deficiency letters.