Chemical/Pharmaceutical development Pre-clinical group can support you from the initial stages of the development of your Pharmaceutical product, whether chemical or biologically sourced.
Active Pharmaceutical Ingredient
Formulation
Analytical development
Manufacture of clinical batches
Stability testing
Regulatory Affairs and QA
Marketing authorization from regulatory agencies dictates on-going project regulatory monitoring.
Our regulatory department will analyze the regulatory
requirements of your project, in accordance we will plan and ensure maximal compliance to international guidelines.
Expert Report Our team of scientists will review all available data and compose comprehensive expert reports for pre-clinical and chemical/ pharmaceutical sections of regulatory submissions.
We prepare summaries and overviews according to the CTD (Common Technical Document) format and applicable ICH guidelines.
