🇬🇲 ValiPro: MCA, WHO GMP & ECOWAS Process Validation Services

Achieve Compliance and Secure Product Registration with The Gambia's Medicines Control Agency (MCA).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in The Gambia. Our documentation is built for full compliance with the rigorous standards of the Medicines Control Agency (MCA), the central regulatory body, which strongly adheres to WHO Good Manufacturing Practices (WHO GMP) Guidelines and the regional harmonization efforts of ECOWAS/WAHO.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and medical supplies, ensuring their validation packages secure timely MCA approvals, minimize review deficiencies, and facilitate product registration in The Gambia and the wider West African region.

🌟 Why MCA-Ready Validation is Crucial

The Medicines Control Agency (MCA) regulates all aspects of medicines and health products in The Gambia. Compliance with their standards is mandatory for market entry and is strictly aligned with international best practices.

• WHO GMP Mandate: The MCA enforces GMP standards that closely follow the WHO Technical Report Series (TRS). Your process validation documentation must conform precisely to these detailed international standards (e.g., WHO TRS Annex 3).

• ECOWAS/WAHO Alignment: The Gambia is a member of the Economic Community of West African States (ECOWAS) and its health arm, the West African Health Organization (WAHO). Submissions are moving toward regional harmonization, often favoring the Common Technical Document (CTD) format.

• Dossier Requirement: Product registration requires the submission of a comprehensive dossier. Validation reports for critical processes (manufacturing, cleaning, analytical methods) are a crucial part of the Quality Module reviewed by the MCA.

🎯 MCA Compliance Focus: Who We Support

We work closely with manufacturers and their local representatives in The Gambia who need:

• Pharmaceutical Exporters: Targeting human and veterinary drug registration with the MCA.

• GMP Conformance: Overseas facilities seeking MCA recognition of their GMP status (based on WHO GMP).

• Dossier Quality: Preparation of the Quality Module ensuring that all manufacturing and control data, including validation, meets MCA expectations.

• Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by MCA assessors regarding manufacturing process controls and capability.

🛠️ Our MCA Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet the MCA's expectations for WHO-aligned quality data.

ServiceMCA / WHO FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS), detailing the process validation lifecycle (Design, Qualification, Continuous Verification).Dossier IntegrationStructuring validation summaries and data precisely for the MCA's required submission format for the Quality Module (often WHO or CTD-based).WHO GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP standards adopted by the MCA.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to MCA assessors, ensuring queries are resolved quickly and effectively.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Medicines Control Agency:

• WHO Technical Report Series (TRS): The primary benchmark for GMP and validation compliance in The Gambia.

• ECOWAS/WAHO Harmonization Principles: Alignment with regional efforts to standardize drug registration dossiers.

• ICH Q8, Q9, Q10: Alignment with these global principles supports the modern, risk-based approach to validation favored by the MCA.

🤝 Get Started on Your MCA Validation

Ensure your process validation documentation is robust and immediately acceptable to the MCA, securing your necessary approvals and market access in The Gambia.

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

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

• Target MCA Status: Product Registration / GMP Compliance Check (New or Renewal)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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