Located minutes from Research Triangle Park (RTP), our North Carolina facility delivers expert chemistry solutions for pre-clinical and early phase clinical supply and can cater for volumes from millilitres up to 200-litre batches, ideal for small volume products or products in the early stages of clinical trials.
Our facility features cGMP API manufacturing capabilities and allows us to produce high value, low volume APIs including high barrier to entry compounds that are generally difficult to manufacture. ... Read more
Our well-equipped GLP analytical laboratory offers a range of analytical services from method development to validation, which is used to support our GMP laboratory. The quality control staff on site are highly trained and oversee all release testing and certification to ensure our products meet the highest standards before being released to the US market for export.
Fast Facts
Established in 1994
55+ employees
27,000 sq/ft facility
50+ molecules
Schedule I to V controlled substances approved
Our North Carolina facility delivers extensive expertise to support a variety of technical requirements for early phase projects.
Some of our key services include:
- Research and development
- Quality control
- Process development
- Reference standards and reference markers synthesis and qualification
- New route development
- Lead optimisation
- cGMP API manufacturing
- Support documentation for IND/ANDA/NDA filing
- Controlled substances
- Analytical method development and validation
Our North Carolina facility is home to an array of specialised equipment to handle comprehensive analytical work and complex chemistries for early phase projects.
Some of the equipment and facilities we have on site at North Carolina include:
- Three GMP synthesis laboratories
- Three research and development laboratories
- Exterior solvent storage
- Analytical wet lab
- Dedicated chromatography lab
- GLP analytical laboratory
- Full range of analytical and quality control equipment, including HPLC, FTIR, LCMS, GC-SH, and moisture analyser
- New research and development lab with 12 fume hoods
Our North Carolina site offers cGMP manufacturing capabilities and an impressive track record in regulatory inspections from the FDA and PAI. We are also committed to protecting our planet, with specific goals in place to continually reduce energy, commuting and waste related emissions.
