Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question
by Massoud Lavian and Paul W. Allen, Clarkston Consulting Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs your company money, time, and reputation. Proactive managers understand the logic behind FDA regulations and prepare accordingly. This three-part survival guide to inspections (whether from FDA, a client, an investor, or a European agency) will sharpen your vision of your company?s regulatory compliance picture.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
