🇭🇹 ValiPro: MSPP/DPM-MT, WHO GMP & Sanitary Registration Services for Haiti

Ensure Compliance and Secure Market Access in Haiti by Aligning with the MSPP's Sanitary Registration and International Quality Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Haitian market. Our documentation is built for full compliance with the rigorous standards enforced by the DPM/MT under the MSPP.

Key compliance pillars include:

• Mandatory evidence of International Quality Standards (e.g., WHO-GMP, FDA, EMA).

• The requirement for Sanitary Registration (Autorisation de Mise sur le Marché, AMM) for all imported products.

• The explicit requirement for product samples and pharmaceutical certification from the country of origin.

🌟 Why MSPP Validation is Crucial

The Haitian regulatory system requires robust documentation to verify the safety and efficacy of imported medicines, given the limited local oversight capacity. Your validation documentation serves as key evidence of quality control.

• Sanitary Registration Mandate: All pharmaceutical products imported into Haiti are subject to Sanitary Registration required by the MSPP. This involves submitting a comprehensive dossier for evaluation.

• International Quality Standards: While the local framework may have limited resources, the DPM/MT requires proof that the manufacturing site adheres to International Quality Standards such as WHO-GMP, FDA, or EU-GMP. Process validation reports, aligned with these international guidelines, are the critical scientific evidence that supports the claim of GMP compliance.

• Dossier Documentation: To satisfy the Sanitary Registration requirements, the MSPP explicitly requires:

  • Information regarding clinical studies and toxicology.

  • Pharmaceutical certification from the country of origin (often a Certificate of Pharmaceutical Product, CoPP).

  • Three product samples of each drug to be imported for potential quality verification.

• Manufacturing Processes and Control: The dossier must include details on manufacturing processes and quality control measures for raw materials, in-process materials, and finished products. The DPM/MT requires this information to confirm the drug meets predefined specifications. The underlying Process Validation and Analytical Method Validation reports are the foundation of this section.

• Language Requirement: Submissions are typically handled in French or accompanied by French translations.

🎯 Compliance Focus: Who We Support

We work with international manufacturers and their local agents targeting the Haitian market:

• Pharmaceutical Exporters: Targeting Sanitary Registration (AMM) for new products.

• NGO & Aid Suppliers: Manufacturers supplying essential medicines through international and non-governmental organizations (NGOs) often require WHO-GMP-aligned validation to meet procurement standards.

• GMP/Quality Compliance: Foreign facilities needing validation documentation that is fully aligned with WHO-GMP principles to support their submitted CoPP and facilitate registration.

🛠️ Our Process Validation Services for Haiti

We provide complete, scientifically sound, and document-intensive support to meet the DPM/MT's high-level requirements for quality assurance.

ServiceHaiti / MSPP / WHO-GMP FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP principles, detailing the entire process validation lifecycle (e.g., three consecutive successful batches), suitable for supporting the required Pharmaceutical Certification.Analytical Validation SupportPreparation of AMV reports for all analytical methods used for Quality Control, ensuring the methods are reliable should the DPM/MT or its delegated laboratory test the three submitted samples.Quality Dossier SummarizationStructuring the manufacturing process description, specifications, and control methods for the Sanitary Registration dossier, emphasizing the link to international quality standards.French Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into French for submission.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards and principles adopted by the MSPP and DPM/MT:

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

• Medicinal Products Act (1955, and subsequent updates): The foundational legislation governing pharmacies and control services.

• International Pharmacopoeias (e.g., USP, Ph. Eur., BP): Used as references for quality testing and specifications.

🤝 Get Started on Your Haiti Validation

Ensure your process validation documentation is robust, meets international quality standards, and is immediately acceptable to the DPM/MT, securing your necessary approvals and market access in Haiti.

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

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

• Target Status: Sanitary Registration (AMM) / Renewal

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

• Existing Data: Any current validation documents or DPM/MT queries.