🇨🇱 ValiPro: ISP, Expedited Review & Bioequivalence Validation Services for Chile

Achieve Rapid Market Acces

The pharmaceutical regulatory authority in Chile is the Public Health Institute (Instituto de Salud Pública, ISP).1 The ISP is a functionally decentralized and autonomous public service overseen by the Ministry of Health (MINSAL).2

The ISP is recognized by the Pan American Health Organization (PAHO) for adhering to high-quality standards and aligns its regulatory guidelines with international frameworks like the ICH (International Council for Harmonisation) and WHO (World Health Organization).3

🇨🇱 ValiPro: ISP, Expedited Review & Bioequivalence Validation Services for Chile

Achieve Rapid Market Access in Chile by Aligning Validation with ISP's High Standards, Utilizing the Expedited Route, and Meeting Strict Bioequivalence Requirements.

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

Key compliance pillars include:

• Mandatory evidence of Good Manufacturing Practice (GMP) from a recognized High Sanitary Surveillance Regulatory Agency (HSA) or WHO/PIC/S member.4

• Mandatory Bioequivalence (BE) Certification for a growing list of Active Pharmaceutical Ingredients (APIs) in oral solid dosage forms.

• Expedited registration through recognition of major international regulatory bodies (FDA, EMA, WHO, PIC/S).5

• Submission of a detailed quality dossier often requiring specific Process Validation Accreditation Forms (e.g., F-VPP 01).6

🌟 Why ISP Validation is Crucial

Chile's regulatory environment is one of the most stringent in Latin America, focusing heavily on Therapeutic Equivalence (EQT), which directly ties into manufacturing process consistency and validation.

• Mandatory Bioequivalence (BE): Law No. 20,724 and subsequent decrees require BE certification for a specific, mandated list of APIs, particularly for generic oral solid forms. The BE study is often tied directly to the manufacturing process validation batch (Biobatch). The ISP requires a dedicated Process Validation Form (F-VPP 01) to present the results for the accreditation of the productive processes used to establish Therapeutic Equivalence.7

• Expedited Procedure: The fastest special registration procedure (around 3 months) is available for drugs approved by major international regulatory bodies (FDA, EMA, WHO, PIC/S).8 This streamlined process relies on the integrity of the original dossier, meaning your validation package must meet the highest international standards (ICH GMP).

• GMP Compliance (HSA Recognition): The ISP requires a valid GMP Certificate issued by an HSA or PIC/S member. The accompanying validation documentation must scientifically justify the quality control and consistency claimed by that certificate. For "Extended Accreditation" of validation, the ISP requires documentation on critical support systems, cleanliness validation, analytical methodology, and manufacturing equipment validation.

• Dossier Documentation: The registration dossier requires extensive technical information, including the formula, the manufacturing process, and quality control.9 Validation reports provide the necessary scientific backing for these sections.

• Language Requirement: Documentation can be presented in Spanish or English. However, if submitted in a language other than Spanish, the ISP requires the respective Spanish translation.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Chilean market:

• Generic Exporters: Requiring validation documentation explicitly linked to the Biobatch and prepared to fill out the mandatory Form F-VPP 01 for process validation accreditation.

• Expedited Route Applicants: Firms leveraging their HSA approval and needing to ensure their existing validation dossiers are fully compliant with ICH quality principles.

• Process Accreditation: Companies needing to compile and review data on critical support systems and cleaning validation to support the "Extended Accreditation" option.

🛠️ Our Process Validation Services for Chile

We provide complete, scientifically sound, and document-intensive support tailored to the ISP's technical requirements and forms.

ServiceChile / ISP / Bioequivalence FocusPVP & PVR PreparationProtocols and reports aligned with ICH Q8/Q9/Q10 principles, covering manufacturing and cleaning processes. The final report is structured to directly support the data fields in Form F-VPP 01.Biobatch DocumentationDetailed documentation and certification of the manufacturing process of the Biobatch to establish the therapeutic equivalence link.Analytical Method Validation (AMV)Preparation of detailed AMV reports for all analytical methods to support the BE study and finished product release.Process Accreditation FormsDirect assistance in completing the mandatory Form F-VPP 01 accurately and comprehensively to avoid automatic refiling or deficiency letters.

📜 Regulatory Standards We Follow

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

• Law No. 20,724 and D.S. No. 3/2010: The foundational legal texts for sanitary registration and therapeutic equivalence.

• ISP Resolutions (e.g., Exenta N°2274/12):10 Specific resolutions detailing the requirements for therapeutic equivalence and process validation accreditation.

• ICH Quality Principles (Q8, Q9, Q10): The scientific basis for validation, recognized by the ISP as a high-vigilance agency.

🤝 Get Started on Your Chile Validation

Ensure your process validation documentation is robust, meets the strict Bioequivalence requirements, and is correctly presented for the ISP's review, securing your approvals and market access in Chile.

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

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size11

• Target Status: Expedited Procedure / Standard Registration (BE required?)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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