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Serving Generic Companies |
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Generic drug manufacturers are making a huge contribution to global health leading to affordable and accessible medicines. We are recognized as a leading CRO serving the generic drug industry.
We have contributed to:
Marketing approval of over 100 generic medicines in six continents, conducting over 500 BA/BE studies. Mentored by the leading generic companies in this service, today we serve several of top 20 global generic companies and leading formulation & marketing companies. Speed to market, thoughtful on current guidelines, sound scientific advice, high credibility with global regulators are some of the attributes of our. We have contributed to First-to-File of Lansoprazole and other molecules.
Generic drug manufacturers are differentiating by following 505(b) (2) pathways. A number of dosage forms and molecules require equivalence to be established conducting BE studies on patients. Our long experience in conducting patient studies in diverse indications in 28 countries helps us meet and exceed sponsor expectations. We have conducted clinical studies in patient populations in an optimal mix of countries and were able to achieve First to File status of Felbamate.
Post marketing issues are sometimes a challenge to generic drug companies as their products get rapidly distributed in several markets. We have supported with post marketing PV service.
Many generic drug companies have invested in biologics to participate in the biosimilar opportunity. As a CRO with experience in conducting Innovator biologic studies and ten biosimilar studies, we are called upon to conduct biosimilar clinical studies.
Successful generic drug companies have invested in developing New Chemical Entities. With a focus on high speed and low program cost, we have participated in research leading to multiple marketing authorizations Our CHF study for an Asian sponsor in Europe and Asia is an example of such a program. When a complex program of a CNS molecule for a global generic company required setting up a dedicated back-office team in DM, Medical Coding, and Statistics, we rose to the occasion with a 20 person team delivering service over four years, leading to a very successful market launch.
We have been consulted on commercialization, partnering strategy, in-licensing evaluation, funding application, as well as clinical trial design and development plan. |
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