The Critical Role of Gap Assessment in Reference Standard Qualification Programs

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,...

Implementation of Primary Reference Standard and Working Reference Standard Procedures in a Biopharmaceutical Company

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...

The Value of Phase-Appropriate Quality Systems in Early-Stage Drug Development

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...

How Biopharma Consulting Group Is Becoming One of the Most Trusted Pharma Consulting Companies in the U.S.

by Jeffrey Wotton | May 30, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification

How Biopharma Consulting Group Is Becoming One of the Most Trusted Pharma Consulting Companies in the U.S. In an industry where precision, compliance, and expertise are non-negotiable, trust is everything. Over the past decade, Biopharma Consulting Group, led by...

How to Prepare for a GMP Inspection: A Consultant’s Perspective

by Jeffrey Wotton | May 30, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Quality assurance compliance consulting

How to Prepare for a GMP Inspection: A Consultant’s Perspective Good Manufacturing Practice (GMP) inspections are pivotal events for pharmaceutical and biotech companies. A successful inspection can affirm your organization’s commitment to quality and regulatory...