Regulatory compliance is essential in all industries, but it is easier said than done. Regulatory agencies strictly monitor organizations to ensure they adhere to the applicable rules and regulations. In doing so, they conduct regular inspections, and companies can...
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Annual Submissions for US in regulatory processes
Annual submissions are critical in regulatorysubmission processes to maintain a product’s quality, safety, and efficacy over its duration in the market. These submissions are part of post-marketing activities for the product and are an essential part of the product’s...
Maintaining Project Documentation and Records in Life Science
Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative, financial, legal, medical), product (physical attributes, study reports, analytical documents, batch records),...
What is an Electronic Quality Management Software (QMS) Solution?
With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As a result, many biotechnology and pharmaceutical companies are turning to electronic quality management software (eQMS)...
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 products, there are many regulations and standards developed by regulatory agencies such as US Federal Food and Drug...
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 a result, many biotechnology and pharmaceutical companies are turning to electronic quality management software (eQMS)...
Outsourcing Supplier Qualification and Auditing
If you work in the life science industry, you know how important it is to maintain the highest standards throughout your product's life cycle - from ideation to the end user. A crucial component of this life cycle is the "supplier." The supplier provides the raw...
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 Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA. The Common Technical Document describes the organization of...
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...