What is an eCTD submission? The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA. The Common Technical Document describes the organization of...
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Structure of the Common Technical Document (CTD)- M4 Guideline
What is the Common Technical Document (CTD)? The Common Technical Document (CTD) format or dossier was designed by the ICH and was agreed upon as a common format between three major regulatory regions, i.e. European Union (EU), USA, and Japan for submission of...
Top 2 FDA Citations to Avoid
The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...
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 medical device industries define a detailed and science-based process for the specification,...
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 learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...
Cybersecurity | Keeping your data safe with eQMS
Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device...
The Pitfalls of Data Migration
Did you know that the FDA regulates data integrity? Pharmaceutical and Medical Device industries must operate in accordance with current Good Manufacturing Practices (cGMP) for regulatory industries, such as the FDA and MHRA, to deem a product as safe for consumers....
Get Your Cleanroom Ready for Business
When you think of a pharmaceutical or medical device company, cleanliness comes to mind when production comes to mind. Cleanrooms are a necessity when it comes to a company's production area. What is a cleanroom exactly? A cleanroom is a controlled environment used in...
Record Keeping and Documentation for GMP compliance
A company's records are a prized possession and should be taken care of the best way possible. When we think of good manufacturing practices (GMP), regulations must be followed to keep the quality and integrity of your records in good standing. Current GMP...
Paperless Validation – What is it and why you need it
Pharmaceutical and biotechnology companies need to assure product quality using validated equipment and computer systems. Computer Systems Validation (CSV) is the process of ensuring that equipment, software, spreadsheets, utilities, and other computerized processes...