🇵🇦 ValiPro: DNFyD, RTCA & Fast-Track Validation Services for Panama

Secure Sanitary Registration in Panama by Meeting the DNFyD's Strict Technical Requirements and Leveraging the New Accelerated Registration Procedures.

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

Key compliance pillars include:

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

• Compliance with Climatic Zone IVb stability conditions.

• Expedited registration through recognition of High Standard Countries (HSCs) and WHO Listed Authorities (WLAs), which demands high-quality, auditable documentation from the country of origin.

🌟 Why DNFyD Validation is Crucial

Panama's recent regulatory changes offer a simplified path for internationally recognized products, but this requires the underlying quality data to meet the highest global standards.

• Expedited Recognition Procedure (Law 419/2024 & Decree 2/2025): Panama now fast-tracks the registration of medicines approved and registered in HSCs (e.g., US, EU) or countries with regulatory authorities on the WHO Listed Authorities (WLA) list. This process relies heavily on the Certificate of Pharmaceutical Product (CoPP) and the complete registration file from the country of origin. Your validation documentation must align perfectly with the standards of that SRA/WLA (e.g., ICH Q7/Q8/Q9/Q10 principles).

• RTCA Governance and Harmonization: Even with the fast track, the process is anchored in the RTCA 11.03.59:18, which outlines the mandatory quality dossier requirements, including GMP certification. The RTCA aims to harmonize the documentation across Central America.

• Climatic Zone IVb Stability: Panama is required to apply Climatic Zone IVb conditions for long-term stability studies. Your process validation must ensure that the manufacturing process is robust enough to produce a product that maintains quality under these accelerated tropical conditions.

• Laboratory Verification Waiver: A major benefit of the new recognition procedure is the elimination of the need for prior laboratory analysis by the Panamanian authorities, provided the product has been registered in a WLA country. This makes the submitted Analytical Method Validation (AMV) and Finished Product Specifications the primary scientific evidence of quality.

• Language Requirement: Submissions and supporting documents, particularly the application form, must be in Spanish.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Panamanian market:

• HSC/WLA Exporters: Utilizing the expedited recognition procedure, requiring flawless compilation and summary of the SRA/WLA-approved quality dossier (often in the CTD format).

• RTCA Compliance: Companies needing validation documentation specifically structured and detailed to satisfy the harmonized Central American Technical Regulations.

• Quality Documentation Integrity: Firms needing to ensure their entire validation package supports the CoPP and GMP Certificate for DNFyD review.

🛠️ Our Process Validation Services for Panama

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

ServicePanama / DNFyD / Recognition FocusPVP & PVR PreparationProtocols and reports aligned with ICH GMP and WHO principles, suitable for supporting the required quality file copy from the country of origin.Analytical Method Validation (AMV)Preparation of detailed AMV reports, compliant with ICH Q2(R1), which become the sole verification of test methods in the expedited route.IVb Stability ReviewEnsuring stability data for the three production batches meets the Climatic Zone IVb requirements ($30^{\circ}C \pm 2^{\circ}C$ and $75\% \pm 5\% RH$).Spanish Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into Spanish for submission via the FADDI platform.

📜 Regulatory Standards We Follow

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

• Law 419/2024 & Executive Decree 2/2025: The recent national regulations governing the registration process.

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

• ICH Quality Principles (Q8, Q9, Q10): The underlying scientific standard for all WLA/HSC recognized processes.

🤝 Get Started on Your Panama Validation

Ensure your process validation and analytical method validation documentation is robust, correctly formatted, and immediately acceptable to the DNFyD, allowing you to successfully leverage the new expedited registration procedure in Panama.

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

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

• Target Status: Expedited Recognition Procedure / Standard Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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