by Jeffrey Wotton | Sep 18, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting
Navigating Post-Approval Changes: How Biopharma Consulting Helps Ensure Compliance and Continuity Securing regulatory approval for a new therapy is a major milestone in the biopharmaceutical industry. But the journey doesn’t end once a drug reaches the market....
by Jeffrey Wotton | Sep 12, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting
Building a Culture of Compliance: How Quality Assurance Consulting Strengthens Biopharma Operations In today’s highly regulated biopharmaceutical landscape, compliance is more than just checking boxes to satisfy inspectors—it’s about building a culture that...
by Jeffrey Wotton | Sep 8, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting
Embracing Digital Twins in Biopharma Manufacturing: Enhancing Quality and Efficiency The biopharmaceutical industry continues to evolve, driven by the need for more efficient production, higher quality standards, and compliance with stringent regulatory requirements....
by Jeffrey Wotton | Aug 29, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Primary Reference Standard, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
The Critical Role of Gap Assessment in Reference Standard Qualification Programs In the biopharmaceutical industry, the establishment of Primary Reference Standards (PRS) and Working Reference Standards (WRS) is a cornerstone of quality control, regulatory compliance,...
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, 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...
