Projects & communication

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.

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