🇸🇬 ValiPro: HSA & ASEAN-Compliant Process Validation Services

Achieve Rapid Product Registration and Regulatory Approval with Singapore's Health Sciences Authority (HSA).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting Singapore, a major hub in the ASEAN region. Our documentation is designed for full compliance with the rigorous standards of the Health Sciences Authority (HSA), ensuring your products meet the highest regional and global quality benchmarks.

We specialize in supporting manufacturers of Western Medicines, Traditional Medicines, Health Supplements, and APIs, helping them secure swift HSA approvals, minimize queries, and efficiently navigate the ASEAN regulatory framework.

🌟 Why HSA-Ready Validation is Crucial

Singapore's Health Sciences Authority (HSA) acts as a highly respected reference authority in the region. Compliance with HSA standards is essential for market access and often facilitates submissions to other ASEAN member states.

• CTD Quality Requirements: HSA mandates that all drug submissions follow the ASEAN Common Technical Document (ACTD) structure, specifically requiring robust Process Validation data in the Quality Module (Part II: Quality, 3.2.P.3.4).

• GMP Acceptance: HSA relies on documented evidence of GMP compliance, particularly validation reports. Our high-standard documentation supports the facility licensing and product registration processes.

• ASEAN Harmonization: Our compliance with ICH Q-series and PIC/S standards ensures your validation documents are readily acceptable not only by HSA but also across the wider ASEAN regulatory network.

🎯 HSA Compliance Focus: Who We Support

We specialize in supporting manufacturers needing compliance with HSA requirements, including:

• Pharmaceutical & API Exporters: Targeting product registration via the HSA's streamlined pathways for prescription and over-the-counter Western Medicines and biologicals.

• Traditional Medicine/Health Supplement Suppliers: Ensuring manufacturing processes are validated to support safety and efficacy claims under HSA's specific regulatory guidelines.

• Regulatory Responses: Firms addressing HSA deficiency letters related to the Chemistry, Manufacturing, and Controls (CMC) section, often involving validation deficiencies.

• PIC/S GMP Readiness: Preparing validation packages that satisfy the rigorous PIC/S requirements adopted by Singapore.

🛠️ Our HSA Process Validation Services

Our services ensure your documentation is technically sound and precisely structured for HSA submission efficiency.

• Preparation of $PV$ Protocols & Reports: Custom-developed documents adhering to the principles of ICH Q8/Q9/Q10 and the three-stage validation lifecycle (Process Design, Process Qualification, Continued Process Verification).

• Gap Assessment (HSA/PIC/S): Reviewing your existing validation documents against HSA’s guidance notes and the globally recognized PIC/S GMP Guide.

• ACTD Part II Quality Data: Structuring and presenting validation summaries and data specifically for the ASEAN Common Technical Document (ACTD) format required by HSA.

• Query Handling: Expert technical support to defend and generate response documents to queries raised by HSA assessors regarding process capability and control.

📜 Regulatory Standards We Follow

Our documentation is designed to align with the core standards prioritized by the Health Sciences Authority:

StandardRelevance to HSAHSA Guidance NotesDirect compliance with all published guidelines for registration of medicinal products and health supplements.PIC/S GMP GuideSingapore is a founding member of PIC/S, making documentation compliant with this guide essential for facility licensing.ICH Q8, Q9, Q10Alignment with these Quality by Design (QbD) principles, which are highly valued in the HSA review process.ASEAN Common Technical Document (ACTD)We ensure the validation data is presented correctly for Module II, the Quality section.WHO Technical Report SeriesUsed as a reference standard, particularly for biologics and public health products.

🤝 Get Started on Your HSA Validation

Ensure your products are validated to the high standards required by the Health Sciences Authority, securing your access to the vital Singaporean market.

To receive a Technical Scope and Commercial Proposal tailored for your HSA submission, simply provide:

• Product: Dosage form (e.g., tablet, liquid, API) and Batch Size

• Target HSA Submission: (e.g., New Drug Application, Generic, Traditional Medicine)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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