🇺🇬 ValiPro: NDA, WHO GMP & EAC CTD Validation Services

Achieve Swift Product Registration in Uganda with NDA-Ready Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in Uganda. Our documentation is built for full compliance with the rigorous standards of the National Drug Authority (NDA), the central regulatory authority, which strongly enforces WHO Good Manufacturing Practices (WHO GMP) Guidelines and requires submissions in the Common Technical Document (CTD) format.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and allied products, ensuring their validation packages secure timely NDA approvals, minimize review deficiencies, and support the mandatory GMP audit process for foreign sites.

🌟 Why NDA-Ready Validation is Crucial

The NDA is responsible for ensuring the availability of safe, efficacious, and quality drugs in Uganda. Meeting their compliance requirements is mandatory and is closely tied to regional and international benchmarks.

• WHO GMP Mandate & Audit: The NDA strictly enforces GMP standards that follow the WHO Technical Report Series (TRS). Foreign manufacturing sites must pass an NDA GMP inspection/audit before product registration is finalized. Robust validation reports are critical evidence required for this audit.

• CTD Submission Format: The NDA requires the registration dossier to be submitted in the Common Technical Document (CTD) format. We ensure your validation reports are correctly presented in Module 3 (Quality), aligning with the NDA's guidelines (PAR GDL 004).

• EAC Harmonization: Uganda is a key member of the East African Community (EAC). Compliance with NDA CTD requirements facilitates participation in EAC Joint Assessments and inspections, often speeding up the process across multiple EAC member states.

• Continuous Compliance: Detailed validation documentation is reviewed during both initial registration and renewal applications, and is necessary for demonstrating the ongoing state of control (Continuous Process Verification).

🎯 NDA Compliance Focus: Who We Support

We work closely with manufacturers and their Local Technical Representatives (LTRs) in Uganda who need:

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

• GMP Conformance: Overseas facilities preparing for the mandatory NDA GMP Inspection/Audit (or the EAC Joint GMP Inspection).

• CTD Module 3 Quality: Preparation of the Quality Module, ensuring that all manufacturing and control data, including process, cleaning, and analytical validation, meets NDA expectations.

• Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by NDA assessors, which can arise from both the dossier review and the audit findings.

🛠️ Our NDA Process Validation Services

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

ServiceNDA / WHO / EAC FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS), detailing the process validation lifecycle and generating the necessary data for the CTD's Quality Module.CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 format required by the NDA (specifically section 3.2.P.3.5, Process Validation).Commitment Batch DocumentationPreparation and review of protocols for commitment batches used for post-approval stability studies.GMP Audit ReadinessReviewing your validation documentation against the NDA's inspection criteria to ensure preparedness for the foreign site audit.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the National Drug Authority:

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

• CTD (Common Technical Document): Compliance with the mandated dossier structure.

• EAC Regional Guidelines: Alignment with regional CTD and GMP assessment requirements.

• ICH Q1A (R2): Compliance with stability testing requirements (often Zone IVB).

🤝 Get Started on Your NDA Validation

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

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

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

• Target NDA Status: Product Registration / GMP Inspection Application

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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