Analytical Development
Isha’s GMP Consultancy has the professional exposure in analytical method development (HPLC, GC) for raw materials, intermediates, drug substances (APIs), and drug products (Formulation) qualification/validation of such methods, and analyses of APIs/Formulation and related materials (raw materials, intermediates).
We possess thorough professional who has upfront knowledge in organic, physical organic/ analytical chemistry. Have in-depth knowledge in handling modern technology, application of specific analytical principles to suit the analytical requirements.
We have an expertise in troubleshooting and problem solving of synthetic processes, comprised of method development/validation of HPLC and GC methods.
Indisputable knowledge and skills evolved in handling diverse instruments to provide support for the new chemical entity or to the formulation development.
We have a proven track record of accomplishment in vast number of analytical methods amidst complex and demanding nature.
We have the leading experience in analytical method development in both proprietary and non-proprietary drug products.
Method development aptly supported by the validation guiding principles according to ICH guidelines.
Isha’s GMP Consultancy literally equipped to carry out the planning, performing, documenting and training the personnel in handling the developed methods.