🇵🇪 ValiPro: DIGEMID, High-Vigilance GMP & CTD Process Validation Services for Peru

Secure Sanitary Registration in Peru by Meeting DIGEMID's Comprehensive Technical Dossier Requirements and Leveraging the New Expedited Approval Routes.

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

Key compliance pillars include:

• Good Manufacturing Practice (GMP): Mandatory compliance with GMP standards, accepting certificates from DIGEMID or a High Sanitary Surveillance Country (PAVS).

• Common Technical Document (CTD) Format: Required for the submission of biological products and increasingly expected for small molecules.

• Validation of Analytical Techniques: Mandatory submission of validation data for analytical methods specific to the finished product.

• Expedited Registration: A streamlined process for products approved in High Health Surveillance Countries (HSC).

🌟 Why DIGEMID Validation is Crucial

DIGEMID is known as a high-complexity agency requiring extensive documentation. The quality and completeness of your validation data are essential to navigate the thorough technical review process and avoid the single, non-extendable deficiency letter.

• GMP Compliance: The dossier must include a valid GMP Certificate from DIGEMID or a recognized PAVS country (e.g., US, EU). The underlying Process Validation and Cleaning Validation reports provide the scientific evidence that supports the certificate's validity.

• Analytical Method Validation (AMV): The regulations explicitly mandate the Validation of the Analytical Techniques Specific to the Finished Product. This must comply with the guidelines established in the relevant Technical Health Standard (e.g., THS No. 147-MINSA/2019/DIGEMID). This is a critical submission requirement.

• CTD Dossier: While not universally mandatory for all small molecules, the CTD format is required for biologicals and is encouraged for alignment with international standards. Process validation reports are summarized and included in Module 3 (Quality).

• Expedited Route for HSC Products (Law 32319): For products approved in HSCs, the registration timeline is significantly reduced (up to 45 days). To qualify, the manufacturer must provide the CTD-aligned documentation approved by the HSC, including the quality section. The Peruvian authority relies on the integrity of the foreign regulatory approval, making the quality of the underlying validation documentation paramount.

• Process Validation Expectation: If the analytical technique for the finished product is an internal method (not compendial), the corresponding validation must be provided. Process validation reports (usually covering three consecutive batches) demonstrate consistency and are essential for proving product quality.

• Language Requirement: Documentation must be in Spanish or accompanied by an official translation.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Peruvian market:

• HSC Exporters: Utilizing the expedited registration process by ensuring their existing validation and quality documentation is perfectly summarized and structured for the Peruvian submission.

• Generic Exporters: Requiring validation documentation that includes the mandatory AMV for the finished product to support the Certificate of Analysis.

• Biologicals & Vaccines: Firms needing full CTD Module 3 compliance (which is required for these products).

• Single Deficiency Avoidance: Companies seeking to ensure their dossier is complete and robust to prevent receiving a final, non-extendable deficiency letter.

🛠️ Our Process Validation Services for Peru

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the DIGEMID submission.

ServicePeru / DIGEMID / CTD FocusPVP & PVR PreparationProtocols and reports aligned with ICH GMP principles, suitable for submission in CTD Module 3 and supporting the GMP certificate.Analytical Method Validation (AMV)Preparation of detailed AMV reports for all in-house finished product methods, directly addressing the mandatory DIGEMID requirement.CTD Module 3 IntegrationExpert compilation and structuring of all quality data (including validation summaries) into the correct CTD Module 3 format.Spanish Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into Spanish for submission.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by DIGEMID:

• Law No. 29459 and Supreme Decree No. 016-2011-SA: The foundational legal framework for registration and control.

• Technical Health Standards (e.g., THS on AMV): Specific guidelines detailing mandatory technical requirements.

• ICH Quality Principles (Q8, Q9, Q10): The scientific basis for validation, necessary for HSC recognition.

🤝 Get Started on Your Peru Validation

Ensure your process validation and analytical method validation documentation is robust, correctly formatted, and immediately acceptable to DIGEMID, securing your necessary approvals and market access in Peru.

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

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

• Target Status: Expedited Registration (HSC) / Standard Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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