0+ years of scale-up & tech transfer experience for Biologics from pre-clinical to commercial manufacturing; Biologics manufacturing, tech transfer/process development, lab validation, regulatory communication; Ex-Apex Biosciences/, Diosynth, Eisai. TG Therapeutics

The BlueWater Group, Inc. helps Organizations LAUNCH, GROW and SUCCEED by providing Strategic Planning, Manufacturing, Quality Management, Engineering, Supply Chain Management, Auditing and Training Services.

Er Ralston brings over thirty years of experience in numerous business improvement interventions. He is an accomplished coach, trainer, and advisor, specializing in operational excellence and planning to facilitate growth and profitability.

We offer an array of rheological tests on materials to quickly and quantitatively model real life applications. Outputs from these tests may provide better insight into product manufacturing, handling, performance, efficacy, and sensory attributes.

ARE YOU DEVELOPING PRODUCTS WITH THE INTENTION OF MARKETING, LICENSING, OR DIVESTING?
DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.

Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

With ISO 17025 accredited services, you will receive a calibration certificate, which exceeds GLP, GMP, ISO 9000 and CAP requirements. Whether you choose mail-in, on-site or pick-up, we will serve your equipment to the highest of standards.

Consultant with 30+ years of experience in biopharmaceutical facility design and validation; clinical and commercial manufacturing; quality systems; regulatory submissions and agency inspections.

A full-service international consulting and product management firm that provides CMC development, manufacturing, regulatory affairs, launch, and operational support to pharmaceutical and biotech companies.​

Cintas Cleanrooms use a highly specialized laundering process with strict standard operating procedures and stringent requirements that meet and maintain ISO 9001 certification. We provide gowning services and cleanroom supplies to ensure that your facility is functioning at peak performance.

Quality Assurance and Compliance; GCP/GLP/GCLP/GMP/CSV/Part 11; Training, auditing, SOPs; drugs, devices, biologics, dietary supplements