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.

Over 40 years of experience in the pharmaceutical industry in both management and technical leadership roles involving development of biotechnology products, drug delivery systems, leading and managing R&D organizations and working effectively with external partners and academic institutions on projects and various technology/innovation initiatives. Broad background and expertise in pharmaceutical sciences, parenteral technologies for development and manufacture of both small and large molecules including monoclonal antibody and peptides, drug product commercialization and knowledge of regulatory expectations for registration of pharmaceutical products in global markets. Understanding of the genetic medicine field with experience in development of lipid nanoparticle delivery systems for gene therapy products and development / manufacture of mRNA based formulations. Expertise in the areas of ADME and biopharmaceutics as applicable to both small and large molecules as well as understanding of subcutaneous absorption of macromolecules and its application to development of patient self-administration delivery systems for biologics. Extensive experience in partnering and collaborating with academic institutions, national research institutes, participating in various consortiums and industrial partnerships to drive the innovation agenda for the organization. Broad experience in conducting due diligence evaluations for assessment of new technologies and in-licensing of both early and late phase clinical assets.

Life Sciences Operations, Supply Chain, Manufacturing, Outsourcing Consulting Services.

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.

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

Pharmaron is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Discovery Chemistry & Biology, CDMO-GMP Manufacturing, CMC Development, Preclinical Development. Please connect to help in your next drug development--cost effective and solid science, IP-protection, BD in NC. One of the large preclinical CROs in India. I live in Chapel Hill.

Embedded Hardware, Embedded Firmware, RF and Antenna Design, Cellular/Bluetooth/WiFi/LoRa/ATSC3/RFID/Wireless Charging, Certifications, Carrier Approval, IoT.

We provide short-term CXO-level support to help you successfully navigate a significant inflection point. We are implementors and action-takers, as well as providing advice and being the CEO's ally. Unlike other short-term C-level providers, we work as a team, so you tap into a wide array of experience and expertise.