We provide pre-formulation and formulation development services for new substances, generics, and existing drugs, including controlled release, excipient optimization, novel drug delivery systems, and scale-up production.
We provide comprehensive analytical development services, including method development, validation, impurity testing, dissolution studies, and compliance with EMA, FDA, ICH, and USP guidelines.
Our team of regulatory affair experts are well versed with global regulatory requirements.Country Specific Dossiers We offer regulatory support towards dossier queries from Authorities.
Variation filing with regulatory bodies according to changing guidelines
We provide end-to-end technology transfer services to facilitate every stages ranging from drug discovery and product development through clinical trials to full-scale commercialization.