Contract Development & Manufacturing Organization (CDMO Services)
Our goal is to offer you the best individually tailored solution for your project and needs.We are a leading service provider in the pharmaceutical industry committed to turning your ideas into success.
Currently we are supplying Drug Intermmediates for R&D, Pilot & Commercial Scale for drug development with complete regulatory documentation.
Our process development services cover all stages of development for your API or advanced intermediate which begins from the project conception, patent landscape evaluation of literature, trials for feasibility, up-scale & optimization enabling us to provide you with the desired amounts of material including CMC documentation.
Our Committed & experienced project managers with scientific backgrounds evaluate, manage and execute the project in accordance with your expectations & targets.
Our target is the development of sustainable, robust, economically viable & competitive processes.
The project will be carried out at one of the trusted and qualified partners of Clearsynth (CDMOs and CROs) with the set-up best-suited to your goals, managed by us and in close alignment with you.
We value your data
We work on the basis of Confidentiality Agreements. The IP shared by you and process know-how resulting from the development contracted by you, is considered proprietary solely to you.
Once the development work is completed, a smooth transfer to the designated production site is targeted.
We can support your development with complementary services in the intellectual property field (FTO analysis, patent applications), quality management, regulatory affairs (strategy, registration), provision of reference & impurity standards etc. as per your individual needs.
What we offer:
- Definition of starting materials & control strategy. Alternatively, we can work on the technical package (RoS as proposed)
- Lab development / feasibility studies
- Patent landscape and FTO analysis - RoS - Route of Synthesis scouting & evaluation
- Analytical method development
- Analytical method validation
- Process development and scale-up - ready for transfer into commercial production
- Synthesis of impurities, reference standards, etc.