After concluding the project, the company has achieved
a clear understanding of the FDA requirements for the
Pre-market submission and they get the Pre-market
submission approval.
About this Case Study
The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA.
A mock inspection was conducted based on 21 CFR 820 requirements, customized to the company’s IVD products and processes.
To learn more about the successful project and the comprehensive results achieved in verifying GMP compliance for the IVD company, download the full case study now.
Discover the step-by-step process, key improvements, and valuable insights that led to FDA pre-market submission approval
Download the Case Study
View other our other resources and company news
CSV Practical Guide to the EMA’s Draft EU GMP Revisions
The EU’s new Product Liability Directive (2024/2853) changes who can be held liable and what damages can be claimed. From software and data loss to ...
Read More
Guide Practical Guide to Post-Market Surveillance (PMS) under EU MDR/IVDR
The EU’s new Product Liability Directive (2024/2853) changes who can be held liable and what damages can be claimed. From software and data loss to ...
Read More
Blog AI for Pharmaceutical SOPs: Transforming Quality Management and Compliance
Rephine helps pharmaceutical and biotech companies transition to digital QMS platforms like Veeva Vault, MasterControl, or TrackWise. From vendor-neutral selection to full GxP-compliant validation and ...
Read More
CAPA Strengthening CAPA & Exceptions Management
Learn how Rephine’s tailored GxP training helped a pharmaceutical manufacturer strengthen CAPA effectiveness, improve compliance, and boost team confidence.
Read More
Blog EU GMP Annex 1 vs FDA Aseptic Guide: Bridging Compliance
EU and U.S. regulators share the same sterility assurance goals, but their approaches differ. Learn how to align Annex 1 and FDA guidance to streamline ...
Read More
Blog GMP & GDP: Ensuring Quality in Drug Storage and Transport
Storage and transport aren’t just logistics — they’re critical GMP processes. Discover how USP helps pharma companies manage risk and maintain quality across global ...
Read More
Blog Blockchain for GMP Documentation: Hype or Future Reality?
Blockchain promises immutability, traceability, and transparency for GMP documentation. But is it a compliance game-changer — or just hype?
Read More
Guide Is Your Insurance Policy Ready for the New EU Product Liability Directive?
The EU’s new Product Liability Directive (2024/2853) changes who can be held liable and what damages can be claimed. From software and data loss to ...
Read More
Article 100% Drug Tariffs in the U.S. – Impact on Pharma Supply Chains & Compliance
The U.S. has announced sweeping 100% tariffs on patented medicines, disrupting pharma supply chains and market access. Discover what this means for manufacturers — and ...
Read More
