First Time US Pharmaceuticals (India) Pvt. Ltd. is an independent testing laboratory providing personalized product development and analytical services to the pharmaceutical and chemical industries. We specialize in Product Development, Analytical Research and Development Testing Services, Quality Control Testing and Stability Storage & Testing Services.
Our goal is to provide high quality, cost effective and timely service, personalized to meet your needs.
First Time US Pharmaceuticals India Pvt. Ltd. has 5000 sq. ft. facility at its Navi Mumbai site dedicated for product development and testing services.
We have combination of state-of-the art analytical instrumentation, manufacturing equipment and, infrastructure meeting global development standards.
Our technology development team consists of scientists drawn from some of the best research universities and organizations around the world.
We offer a highly qualified laboratory team with extensive pharmaceutical experience and excellent knowledge of FDA/cGMP requirements. Our program managers and chemists bring years of laboratory experience with unique entrepreneurial perspective. We have a knowledgeable team that understands all aspects of manufacturing, product development, quality assurance and regulatory compliance.
Our dedicated team of employees are experienced in developing and testing a variety of products and dosage forms including but not limited to oral formulations like, liquid, suspension, powder, pellets, capsule, tablets, immediate, delayed, controlled or sustained-release. We take pride in our ICH-compliant stability management program for stability testing.
We provide regulatory services including but not limited to:
We also offers complete product development package including product development report based on Quality by Design. The services can also be extended to completion of successful of human biostudies for submission. We specialize in developing product such as immediate, sustained, delayed, controlled release tablet or capsule and oral liquid.
Our modern product development equipment include
Various testing equipment such as hardness tester, friabilator, disintegrator, dissolution tester, moisture analyser.
We offer stability indicating analytical method development, verification and validation services in compliance with FDA and ICH guidelines. Method development and validation can be performed based on in-house or client supplied protocols.
The method development and validation services include providing test methods and validation reports drafted to in-house requirements or client specifications.
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First Time US Pharmaceuticals India has not received any endorsements.