We can help you leading and managing projects – or facilitation of workshops/process optimization. Furthermore, we provide tailor made courses within areas of CMC and regulatory requirement (examples provided below).
Course in Drug analysis and method validations
Half day course: Get to know you drug molecule better.
- What information is needed to describe the properties of the drug (small molecule) and how is this information obtained (stability, solubility, dissolution etc).
- How can computer simulations contribute to understanding of the in vivo behaviour.
- When is “GMP” required, and how is the right level defined.
- What is the practical approach to instrument qualifications and method validations.
Course in Regulatory requirements for development specialists
Half day course: Training of development specialists in the regulatory requirement (‘101 on regulatory requirements for development departments’) including:
- Stability program through out development to meet the requirements for clinical trials and marketing authorisation application.
- Classification of variation applications due to changes in the process/analyses for an approved product,
- Identification of needed documentation before submission.
Scientific project management
In the pharmaceutical industry, leading a project is not “just” to secure overall timelines: It is about knowing the details about requirements, knowing when optimisation is possible or when additional studies are needed.
We can help you in structuring – and in execution of complex projects within matrix organisations. Furthermore, we can be your trusted link to CMO/CRO’s, securing that you get what you expect – and on time.