by Jeffrey Wotton | Aug 29, 2025 | Biopharma Consultant, Biotech Consulting, Case Study, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Primary Reference Standard, Quality assurance compliance consulting, Quality Control, Working Reference Standard, Working standard qualification
Implementation of Primary Reference Standard and Working Reference Standard Procedures in a Biopharmaceutical Company A case study from BioPharma Consulting Group Background Biopharmaceutical Company A, a mid-sized company specializing in monoclonal antibody...
by Jeffrey Wotton | Aug 13, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Understanding the Importance of Working Standard Qualification in Biopharmaceutical Manufacturing In the highly regulated world of biopharmaceutical manufacturing, precision, consistency, and compliance are non-negotiable. One critical element in achieving these...
by Jeffrey Wotton | Jul 21, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Understanding Primary Reference Standards (PRS) in Pharmaceutical Development Why Primary Reference Standards Are the Cornerstone of Reliable Analytical Testing in Pharma. In the pharmaceutical industry, accuracy and consistency are non-negotiable. One critical...
by Jeffrey Wotton | Jun 20, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Quality assurance compliance consulting
The Value of Phase-Appropriate Quality Systems in Early-Stage Drug Development For early-stage biotech and pharmaceutical companies, one of the most common challenges is determining how much quality infrastructure is necessary during the earliest phases of...
by Jeffrey Wotton | Jun 6, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting
The Role of Biotech Consulting Firms in Advancing Emerging Therapies The biotech industry is experiencing a wave of innovation unlike any other period in its history. From personalized medicine and gene editing to mRNA vaccines and cell therapies, emerging...
