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,...
by Jeffrey Wotton | Apr 18, 2025 | Biopharma Consultant, Insights
Bridging the Gap Between R&D and Commercialization in Biopharma In the high-stakes world of biopharmaceutical development, the path from laboratory research to commercial product is rarely linear. Complex regulatory landscapes, evolving quality requirements, and...
by Jeffrey Wotton | Apr 11, 2025 | Biopharma Consultant, Insights, Pharma Consulting, Quality assurance compliance consulting
How Phase-Appropriate Quality Systems Support Scalable Growth in Biotech As biotech and emerging pharma companies move from discovery to clinical and ultimately toward commercialization, their quality systems must evolve in lockstep. Trying to apply a...
by Jeffrey Wotton | Apr 11, 2025 | Biopharma Consultant, Insights, Pharma Consulting, Working Reference Standard, Working standard qualification
Key Considerations When Selecting a Working Reference Standard A well-qualified working reference standard (WRS) is the cornerstone of consistent analytical testing in pharmaceutical and biopharmaceutical manufacturing. But before qualification begins, choosing the...
by Jeffrey Wotton | Apr 4, 2025 | Biopharma Consultant, Insights, Pharma Consulting, Quality assurance compliance consulting
Leveraging a Biopharma Consultant for Regulatory Filing Readiness In the fast-paced world of pharmaceutical and biotechnology development, successfully navigating the regulatory landscape is a critical step toward bringing a product to market. From IND...
by Jeffrey Wotton | Apr 1, 2025 | Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Understanding the Difference Between Working Standards and Reference Standards in Biopharma In the biopharmaceutical industry, accurate and consistent analytical testing is essential to ensure product quality, safety, and regulatory compliance. One of the key...
