🇳🇮 ValiPro: MINSA/DGRS, RTCA & GMP Process Validation Services for Nicaragua

Ensure Compliance and Secure Sanitary Registration in Nicaragua by Meeting the DGRS's Technical Documentation Requirements, as Mandated by the RTCA.

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

Key compliance pillars include:

• Mandatory adherence to the Central American Technical Regulation (RTCA) 11.03.59:18 for sanitary registration.

• Reliance on a GMP Certificate and detailed technical information to verify safety and quality.

• Submission of validated analytical methodology and stability studies for three batches.

🌟 Why DGRS/RTCA Validation is Crucial

Nicaragua's commitment to the RTCA means the quality documentation must be structured to meet the regional technical requirements.

• RTCA and Legal Mandate: Registration is governed by the national Medicines and Pharmacy Law (Law No. 292) and the regional RTCA 11.03.59:18. This regulation dictates the specific technical and pharmacological documentation required.

• GMP Compliance: The dossier requires evidence of Good Manufacturing Practice (GMP) compliance. This is typically a GMP Certificate or a Certificate of Pharmaceutical Product (CoPP) from the country of origin. The DGRS may recognize high-level regulatory authorities (Level IV). Your process validation reports, aligned with WHO/ICH GMP principles, are the scientific evidence that supports the integrity of the manufacturing process claimed in these certificates.

• Required Validation Data: The technical documentation explicitly mandates:

  • Validated Analytical Methodology: The validation of all analytical methods used to control the finished product quality must be submitted. This data should be clear, detailed, and aligned with ICH Q2(R1) principles to ensure the methods are reliable.

  • Stability Study: The dossier requires a stability study and supporting data (often from three production batches) to justify the declared shelf-life, which necessitates a well-validated process.

• Process Validation Expectation (Three Batches): While the RTCA provides the general framework, international guidelines (often referenced by regulatory bodies in the region) typically require validation data from at least three consecutive, successfully validated production batches to prove consistency and reproducibility.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Nicaraguan market:

• Pharmaceutical Exporters: Targeting Sanitary Registration for human-use products.

• RTCA Compliance: Companies needing validation documentation specifically structured and detailed to satisfy the RTCA requirements for Central America.

• Quality Documentation Integrity: Firms needing to ensure their validated analytical methodology and finished product certificates are robust enough for the DGRS's technical evaluation.

🛠️ Our Process Validation Services for Nicaragua

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

ServiceNicaragua / DGRS / RTCA FocusPVP & PVR PreparationProtocols and reports aligned with WHO/ICH GMP principles, demonstrating control over the critical manufacturing process steps, often covering three batches.Analytical Method Validation (AMV)Preparation of detailed Validated Analytical Methodology reports, compliant with ICH Q2(R1), for submission in the technical information section.Dossier Compliance ReviewReviewing the technical information (formula, specifications, stability data) against the latest RTCA 11.03.59:18 requirements.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 the DGRS:

• Central American Technical Regulation (RTCA) 11.03.59:18: The primary regulation for Sanitary Registration.

• WHO/ICH GMP Principles: The recognized international benchmark for manufacturing practice compliance.

• ICH Q2(R1): The standard for Analytical Method Validation.

🤝 Get Started on Your Nicaragua Validation

Ensure your process validation and analytical method validation documentation is robust, correctly translated, and immediately acceptable to the DGRS, securing your necessary approvals and market access in Nicaragua.

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

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

• Target Status: Sanitary Registration / Renewal

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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