Guidance on Common Regulations and Standards
Whether a company is in the life science industry, or providing products in the pharmaceutical, biological, medical devices, cosmetics, veterinary…
Manufacturing Equipment and Laboratory Equipment Validations
With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As…
Outsourcing Supplier Qualification and Auditing
If you work in the life science industry, you know how important it is to maintain the highest standards…
Difference Between CTD and eCTD Submission Formats
What is an eCTD submission? The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common…
Quality Risk Management for Commissioning and Qualification
Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and…
Inspections and Audits: What You Need to Know
Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and…
