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...
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...
by Jeffrey Wotton | May 30, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Stability Testing Strategies for Working Standards In the biopharmaceutical industry, maintaining the integrity and reliability of analytical results is paramount. One crucial element in achieving this is ensuring the stability of working reference standards (WRS)....
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...
by Jeffrey Wotton | May 2, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Key Considerations for Maintaining Qualified Working Standards Over Time Establishing a qualified working standard is only the beginning of a larger commitment to data integrity, product consistency, and regulatory compliance. Once a working standard is qualified,...
