Formulation Services include but not limited to all known dosage forms starting from pre-formulation studies, product and process design, technology transfer up to commercialization.
Analytical Services include but not limited to API, excipient, packaging material and RLD characterization, method development, method validation, method transfer and stability studies. The services also include elemental analysis, residual solvent and physico-chemical characterization of dosage form.
Regulatory and compliance services include regulatory consulting for product approval in both regulated and semi regulated markets. We provide assistance for ANDA, / NDA applications, DMF /ASMF. The compliance services include inspection, auditing, training and consultancy.
Contract Manufacturing include technology transfer to our US manufacturing site that include various dosage forms like solid/liquid oral dosage, transdermal and topical products.
IPR can guide to our US patent team related to patent infringing/ non-infringing issues.
Regulatory and Compliance
USFDA USFDA USFDA registered and audited facility.
First Time US Pharmaceuticals (India) Pvt. Ltd.
An innovative entrepreneurial healthcare company with focus on services assuring quality and timeliness.