🇦🇴 ValiPro: ARMTS & WHO GMP Process Validation Services

Achieve Compliance and Secure Product Registration with Angola's Regulatory Agency (ARMTS).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Angolan market. Our documentation is built for full compliance with the requirements of the Agência Reguladora de Medicamentos e Tecnologias de Saúde (ARMTS), which strongly enforces WHO Good Manufacturing Practices (GMP) Guidelines and other recognized international standards, particularly for imported medicines.

We specialize in supporting manufacturers of human medicines, APIs, and medical supplies, ensuring their validation packages secure timely ARMTS approvals, minimize review deficiencies, and facilitate product registration in Angola.

🌟 Why ARMTS-Ready Validation is Crucial

The ARMTS is the regulatory body responsible for drug and health technology regulation in Angola. Compliance with their standards, which are heavily influenced by WHO and Portuguese-speaking (CPLP) best practices, is mandatory for market entry.

• WHO GMP Reliance: The ARMTS regulatory framework adopts and enforces WHO GMP guidelines. This means your validation documentation must align with WHO's expectations for quality systems and process control (e.g., WHO TRS Annex 3).

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

• GMP Assessment: Foreign manufacturers must provide documents demonstrating GMP compliance. Our robust, WHO-aligned validation documentation is essential evidence for demonstrating a state of control during the ARMTS's assessment process.

🎯 ARMTS Compliance Focus: Who We Support

We work closely with manufacturers and their local representatives in Angola who need compliance with the following:

• Pharmaceutical Exporters: Targeting human drug and API registration with the ARMTS.

• GMP Conformance: Manufacturers requiring documented evidence of WHO GMP conformance for their entire manufacturing and control systems.

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

• Regulatory Responses: Firms addressing deficiency letters or quality queries issued by ARMTS assessors regarding manufacturing process controls and capability.

🛠️ Our ARMTS Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet the ARMTS's expectations for quality data and process control.

ServiceARMTS / WHO FocusPVP & PVR PreparationCustom protocols and reports structured to address WHO GMP (TRS) validation principles, including the demonstration of process capability and robustness.Analytical ValidationPreparation of detailed Analytical Method Validation Reports to ensure testing procedures meet international and local standards for quality control.Dossier IntegrationStructuring validation data to be easily incorporated into the ARMTS's required submission format for the Quality Module.Gap AssessmentReviewing current validation procedures against the adopted WHO GMP and any specific ARMTS regulatory circulars.Query HandlingProviding expert technical defense and drafting responses to quality and validation queries from ARMTS assessors.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards prioritized by the ARMTS:

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

• ICH Q8, Q9, Q10: Alignment with these global principles ensures that the process lifecycle approach is acceptable, demonstrating a modern, risk-based approach to validation.

• CPLP Guidelines: Awareness of regulatory best practices from the Community of Portuguese Language Countries (CPLP), which often influence Angolan standards.

• EU/US FDA Standards: Used as reference standards for advanced technical depth, which aids in gaining ARMTS regulatory confidence.

🤝 Get Started on Your ARMTS Validation

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

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

• Product: Dosage form (e.g., tablet, injectable) and Batch Size

• Target ARMTS Category: (e.g., Human Drug, API, Medical Device)

• Target Status: New Registration / Renewal / GMP Compliance Check

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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