Quality Assurance (QA) is central to pharmaceutical and biotech compliance, but maintaining a full i...
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Environmental Risk Assessment (ERA) is a mandatory part of the marketing authorization process for m...
Annual Product Reviews (APR) and Product Quality Reviews (PQR) are non-negotiable in pharma. Yet whe...
For medical device startups, market access and investor trust hinge on a robust Quality Management S...
Since the FDA announced in May 2025 the expansion of unannounced inspections at foreign manufacturin...
In the development of pharmaceutical products, ensuring the safety and compatibility of container-cl...
The pharmaceutical industry’s journey with nitrosamines has been one of the most significant quality...
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GMP compliance isn’t just about ticking boxes; it’s a safeguard for patient safety and product quali...
Balancing efficiency, cost, and compliance is a growing challenge for organizations—particularly in ...
Annual Product Reviews (APR) and Product Quality Reviews (PQR) are essential for compliance in the l...
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In today’s globalized and highly regulated supply chain, keeping pharmaceutical products safe and ma...
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Since August 25, 2023, the pharmaceutical industry has been operating under a new standard for steri...
Audits play a central role in ensuring regulatory compliance, product quality, and operational integ...
The Quality Audits should be managed according to the Quality Management System requirements , which...
In the pharmaceutical and medical device industries, maintaining compliance with regulatory standard...
In the dynamic healthcare industry, maintaining efficiency and compliance isn’t just a necessity—it’...
In a previous blog post, we talked about the various activities that take place during an inspection...
In May 2022, the European Union (EU) ushered in the In Vitro Diagnostic Regulation (IVDR), marking a...
In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Complianc...
On January 31, 2024, the US Food and Drug Administration (FDA) published its long-anticipated final ...
In healthcare, safeguarding patient safety and upholding the integrity of pharmaceutical interventio...
In the complex and highly regulated world of pharmaceuticals, the synergy between Quality and Regula...
EU GMP Annex 1’s revision – the 2022 update to ‘ Manufacture of Sterile Medicinal Products‘ – aimed ...
Regulatory agencies require internal and supplier audits in the pharmaceutical and medical device in...
Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s c...
Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 ...
Dendritic cells (DCs) are crucial cells in the initiation and regulation of the adaptive immune resp...
Ideation and feasibility phase Every medical device invention, from a simple syringe to an advanced ...
How to guarantee medicine quality and patient safety To explain the quality by design methodology, i...
What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs)...
First of all, let’s take a look at the manufacturing flow of vaccines. The production process consis...
Imagine guiding someone through Excel’s myriad functions in a written manual. Where to begin? With b...
After months of revision and many questions raised, it now appears that the time is coming to implem...