– Examples of services

Evaluation of drug properties

• Is the drug substance suitable for further development? The compound should be in a stable form and should have appropriate solubility/dissolution rate in order to be bioavailable. We can advice you on the required analysis package and/or participate in selection of a CRO to perform the analyses. Furthermore we can write the suitability report.

Stability program

• A strategy for the stability program on the pharmaceutical compound should be available before starting clinical trials: We can support you in designing the appropriate stability program. We can also help you writing protocols and reports.

Getting ready for clinical trials

• Clinical trial applications require an IMPD where the drug properties are described: We can compile or write the CMC/product related documents either based on input from the customers – or a full package, where we also are responsible for ordering and analyzing  the data from CMO/CRO’s.
• If you need help with the non-clinical and clinical sections, we coorperate with experts in our network within these areas.

Technical writing and regulatory review

• Do you wish to be ready before an audit or submission, or do you need an extra set of hand during a busy time period? We can provide technical writing and/or regulatory review of development reports and protocols as well as SOPs, change control cases and deviation reports.