Category: Biopharma

ICH: Guideline on Testing for Carcinogenicity of Pharmaceuticals, an Addendum

August 30, 2021
Biopharma

Over the course of drug development, it is important for sponsors to develop a scientifically robust strategy for carcinogenicity assessment that considers key biologic, pharmacologic, and toxicologic...

Addendum, Guideline on Testing for Carcinogenicity, Pharmaceuticals, Testing for Carcinogenicity of Pharmaceuticals

Regulatory Intelligence is a key to Quality and Safety

January 29, 2021
Biopharma

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on...

Regulatory Affairs, Regulatory Changes, Regulatory Database, Regulatory Intelligence, Regulatory Intelligence for Biopharma, Regulatory Intelligence for Cosmetics, Regulatory Intelligence for Food Supplements, Regulatory Intelligence for Medical Devices

Clinical Intelligence for better Clinical Trials

January 29, 2021
Biopharma

Every sector including healthcare is based on data nowadays. The only issue with healthcare is the complexity of the clinical data. The constant regulatory changes added with the rising competitions...

Clinical Intelligence, Clinical Intelligence in Clinical Trials, Role of Clinical Intelligence:

Regulatory Challenges for Combination Products

March 30, 2020
Biopharma

In the dynamic and ever changing global regulatory outlook, the area of combination products is an exciting expanse of attainable innovation and discovery for both the drug and medical device industries....

Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

March 17, 2020
Biopharma

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements...

USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

March 17, 2020
Biopharma

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance...