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