Testimonials
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Successful CMC for Clinical Entry
Providing CMC capabilities, knowledge and experience to ensure products move smoothly into clinical studies
“provided the capability that we needed and provided knowledge-based guidance on developing a manufacturing process that resulted in clinical trial material for our first-in-man trial”- Dr. Pamuk Bilsel, Chief Scientific Officer
- Flugen Inc.
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Assay development & Validation
Assay development – including design, optimisation through to validation
“The experience in the different types of assay development & validation proved very valuable"- Dr. Gary Khoo, Director of CMC
- Takeda Vaccines Inc.
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Process Development & Validation
Process development – including process design, optimisation through to validation
“Working with GRA has many advantages. One example is the extraordinary network of Associates from different scientific areas that GRA has built over the years. This brings specific know-how to exactly where it is needed for only as long it is needed; a very sophisticated approach. A combination of Lee's personal expertise combined with the know-how from the Associates brings project development to the next level”- Dr. Matthias Müllner - SVP Technical Operations
- Merck Sharp & Dohme GmbH
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Invested & Committed to Your Programs
Committed to ensuring delivery of the program through both the design and execution stage of the program
“We felt that our projects were important to Lee, and see him as a part of the team rather than as a consultant who shares his views and runs away thereafter…”- Dr. Eric Tauber, CEO
- Themis Bioscience GmbH
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Biologics CMC Capabilities
Providing CMC capabilities, knowledge and experience to ensure product are readiness for clinical studies
“Lee is an industry expert with technical knowledge about biologics that extends from research to CMC through to regulatory"- Dr. Jill Livengood
- Inviragen Inc.
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Expertise in your Hands
Helping ensure programs are right first time by using our expertise
"In a highly regulated environment GRA helped us fully understand the data we're generating and what it actually means"- Dr. Joseph Santangelo, VP, CMC
- Takeda Vaccines Inc.
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Statistical Analysis & Training
Training & support in the application of statistical analysis on complex data sets
“I really enjoyed the part of learning statistics and how it can be applied to increase our understanding of processes but not only manufacturing but also analytical.- Dr. Jordi Esparza, Head of Analytical Development
- Takeda Vaccines Inc.
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Commercialisation of Devices
Helping companies to negotiate deals, develop diagnostic technologies and move the business forward
“All round experience in commercialisation and industrial R&D”- Dr. Alexander Edwards, Director
- Capillary Film Technology Ltd.
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Diagnostics Business Development
Supporting diagnostic companies to negotiate deals, develop the technology & helping to grow your business
“Very talented & capable with strong leadership skills and business management capabilities”- Johnson Chen, Managing Director
- Clearbridge Accelerator Pte Ltd.
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Evaluation of Commercial Opportunties
Evaluation of opportunities & due diligence
"It was a pleasure working with you"- Dr. Sung Lee, Manager
- Abcam plc.
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Biotech Due Diligence
Whether you’re looking to invest in biotechnology or looking for your company to withstand due diligence
“Came in with a very strong problem solving attitude from the beginning and struck the right balance of telling us what we didn’t know while respecting that we were not totally ignorant”- Paul Radspinner, CEO
- Flugen Inc.