Method Development Services

NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and are intended for supporting early stage formulation development and late stage commercial production scale up. GMP NIR methods are for tablet content uniformity testing and can be used for supporting NDA/ANDA filings. NiRACLE also assists clients in developing real-time process monitoring methods for various unit operations including blending, film coating and granulation. The services also include experimental design, method validation and method transfer.