🇨🇷 ValiPro: DRPIS, ICH & RTCA Process Validation Services for Costa Rica

Secure Product Registration in Costa Rica by Aligning with the DRPIS's High Quality Standards and Leveraging the 30-Day Recognition Procedure.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Costa Rican market. Our documentation is built for full compliance with the rigorous standards enforced by the Dirección de Regulación de Productos de Interés Sanitario (DRPIS).

Key compliance pillars include:

• Mandatory evidence of Good Manufacturing Practice (GMP) compliance, typically via a Certificate of Pharmaceutical Product (CoPP) and/or a GMP certificate from a recognized authority.

• Explicit requirement for Validation of Method of Analysis (Analytical Validation).

• An accelerated path for products approved by ICH member authorities.

🌟 Why DRPIS Validation is Crucial

Costa Rica has a two-tiered system for drug registration: the standard procedure (typically 12-15 months) and a recently streamlined 30-day recognition procedure for highly regulated products. Both demand comprehensive quality data.

• Analytical Method Validation (AMV) is Mandatory: The registration dossier explicitly requires the submission of the Method of Analysis (Finished Product) and the Validation of Method of Analysis (Finished Product). This AMV must align with international standards, such as ICH Q2(R1).

• ICH Recognition Procedure (30 Days): As of a recent decree (No. 43590-S), pharmaceutical products approved by an ICH member regulatory authority (e.g., EMA, FDA, Health Canada, MHLW/PMDA) can undergo a recognition procedure, reducing the timeline to approximately 30 days. To utilize this route, the product must be identical to the one approved by the ICH authority, meaning the underlying quality and validation data must meet that SRA's standards (e.g., EU GMP Annex 15).

• GMP Compliance: The dossier requires a Certificate of Pharmaceutical Product (CoPP) and a GMP Certificate from the country of origin. While the DRPIS may not routinely conduct foreign inspections, the submitted validation data must be robust enough to support the claims of control made in these certificates.

• Central American Technical Regulations (RTCA): Costa Rica is part of the Central American Integration System (SICA) and follows the RTCA regulations (e.g., RTCA 11.03.59.18 for pharmaceutical products). This regulation outlines harmonized requirements across the region, including stability studies and quality documentation.

• Language Requirement: All documents must be provided in Spanish or be accompanied by an official translation.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Costa Rican market:

• ICH/SRA Exporters: Utilizing the 30-day recognition procedure, requiring rapid and high-quality compilation of the SRA-approved quality dossier data.

• Standard Registration: Companies pursuing the standard national route, needing precise alignment with the DRPIS-mandated quality document list.

• Analytical Validation: Firms needing robust AMV reports specifically compliant with the DRPIS explicit requirement for method validation.

🛠️ Our Process Validation Services for Costa Rica

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

ServiceCosta Rica / DRPIS / ICH FocusPVP & PVR PreparationProtocols and reports aligned with ICH/WHO GMP principles, suitable for supporting the required manufacturing process description and control strategy.Analytical Method Validation (AMV)Preparation of detailed Validation of Method of Analysis reports for the finished product, fully compliant with ICH Q2(R1).ICH Dossier ReviewReviewing existing quality dossiers against the specific requirements for the 30-day recognition procedure to ensure no documentation gaps (e.g., stability data, complete filing copy).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 DRPIS:

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

• Central American Technical Regulations (RTCA): The harmonized regulation for product quality and registration requirements.

• ICH Quality Principles (Q8, Q9, Q10): The underlying scientific foundation for GMP compliance.

🤝 Get Started on Your Costa Rica Validation

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

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

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

• Target Status: ICH Recognition Procedure / Standard Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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