Contract Development of Intermediates and Drug Substances

Customized and tailor made to your particular requirements

Our services cover all stages of development for your API or advanced intermediate starting from the project conception, through evaluation of literature, patent landscape and/or technology packages, feasibility trials, up-scale & optimization, in order to provide you with the desired amounts of material including CMC documentation.

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.

Our target is the development of sustainable, robust, economically viable & competitive processes.

Committed Midas project managers with scientific & expert backgrounds will evaluate, manage and execute the project in accordance with your expectations & targets.

The project will be carried out at trusted and qualified partners of Midas (CDMOs and CROs) with the set-up best-suited to your goals, managed by Midas and in close alignment with 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.

We look forward to your inquiry!

Our services:

• Patent landscape and FTO analysis
• RoS – Route of Synthesis scouting & evaluation
• Definition of starting materials & control strategy. Alternatively, we can work on the technical package (RoS as proposed)
• Lab development / feasibility studies
• Specifications
• Analytical method development
• Analytical method validation
• Process development and scale-up – ready for transfer into commercial production

Additional services

• Genotox / carry over studies
• Synthesis of impurities, reference standards, etc.
• Salt screening, co-crystal screening, polymorphism studies
• Regulatory services – CMC section or full ASMF