img

Research and Development

The department of Research & Development develops synthesis routes and analyses for active pharmaceutical ingredients (APIs). They work mainly for clients and develop APIs for the human and veterinary market. All developments are worked according to the guidelines set by Good Manufacturing Practices (GMP) ICH Q7 and ISO 9001-2010.

Research

When the department of Research and Development receives a request from a client, they will first carry out research on patents, literature, practical feasibility etc.

When positive advice is given, a project manager will be appointed, from then on he will be your contact person and all communications will be taken care of by him.  

Start project

The product is developed through continuous communication between the organic chemists, the research analysts and the RA and QA department. If the product can be synthesized on a small scale, upscaling will be started until the required scale is reached.

The RA department validates the analyses and syntheses and writes an Active Substance Master File (ASMF).If applicable a CEP will be requested. Specific unique projects are patented and/or filed.

During this entire process the project manager will keep in touch with the customer. He/she will explain the state of affairs and inform the customer of what the next step will be.
 

Completion project

After the ASMF is submitted by the client, a Change Control request is submitted to the QA department. They then ensure that all documentation concerning the products is in accordance with the GMP-directive. This means Batch History Records, clean up validations etc.

Contact

If you are interested in what the Research & Development department can do for you, please contact us. All requests are confidential. If desired, before details are known there can be a confidential disclosure agreement signed.