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What are the Responsibilities of the Quality Control Unit?
In the realm of regulated industries, maintaining product quality is of utmost importance. To ensure the safety, efficacy, and...
efrainma88
Jul 6, 20233 min read
Ensuring Quality from Start to Finish: Vendor Management and Supplier Qualification
In the dynamic and highly regulated field of life sciences, effective vendor management and supplier qualification play a critical role...
BioBoston Consulting
Jul 5, 20233 min read
Sterility and Contamination Control in Pharma and Biotech
Pharmaceutical and biotechnology companies play a critical role in improving human health and well-being. Ensuring the safety and...
BioBoston Consulting
Jul 3, 20234 min read
US and EU GMPs: Key differences
Good Manufacturing Practices (GMPs) play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical and healthcare...
BioBoston Consulting
Jun 29, 20234 min read
ICH S12: Nonclinical Biodistribution Considerations for Gene Therapy Products
ICH S12 is a new guideline that provides harmonized recommendations for the nonclinical biodistribution (BD) assessment of gene therapy...
BioBoston Consulting
Jun 28, 20232 min read
FDA Releases New Guidance on Pediatric Drug Development
The U.S. Food and Drug Administration (FDA) has released two draft guidance documents on pediatric drug development. The guidance...
BioBoston Consulting
Jun 27, 20233 min read
Essential Skills for Quality and Regulatory Consultants
As the pharmaceuticals, biotechnology, and medical devices industries continue to evolve, the role of Quality and Regulatory Consultants...
BioBoston Consulting
Jun 26, 20234 min read
Overcoming Supply Chain Challenges in the Life Science Industry
Supply chain management plays a crucial role in the life science industry, encompassing pharmaceutical, biotechnology, and medical device...
BioBoston Consulting
Jun 23, 20232 min read
The Benefits and Challenges of Decentralized Clinical Trials
New FDA Guidance Provides Recommendations for Conducting Decentralized Clinical Trials The Food and Drug Administration (FDA) has...
BioBoston Consulting
Jun 22, 20232 min read
What is Computer System Validation?
In today's rapidly advancing technological landscape, computer systems play a crucial role in the life science industry, enabling...
BioBoston Consulting
Jun 21, 20234 min read
ICH Q9(R1): A New Standard for Quality Risk Management in the Pharmaceutical Industry
The pharmaceutical industry is a highly regulated industry, and the quality of pharmaceutical products is of paramount importance. In...
BioBoston Consulting
Jun 20, 20232 min read
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