Range of Capabilities

Medical Writing

* Writing of preclinical and clinical expert reports according to CTD rules (modules 2.4, 2.5, 2.6, 2.7)

Experience regarding evaluation of newly developed drugs, biosimilars and generic drugs, herbal medicinal drugs; homeopathic drugs, OTC drugs, parenteral nutrition

Medical devices

Indications (main focus): CNS and peripheral nervous system, cardiovascular system, metabolism and nutrition (TPN), diabetes, urology, dermatology, infectious diseases, immunology, asthma, GI- syndrome, oncology, endocrinology, anaesthesia 

* Investigator brochures

* SMPCs, PIL, Product Labelling

* Toxicological evaluation of active and auxiliary ingredients, raw material in dermatologic- / cosmetic products

* Determination of Permitted Daily Exposure (PDE) in the context of cleaning validation 

* Processing of deficiency letters („Mängelrügenbescheide“)

* Environmental risk assessment of drugs (according to EM(E)A-guidelines)

* Study protocols, final reports of clinical trials

* Ghost-writing of manuscripts for “peer-review“ 

*Medical devices incl Biocompatibility Assessment according to the requirements of DIN EN ISO 10993 and Clinical Evaluation Reports

Drug safety/ pharmacovigilance

* PSURS, RMPs

* continuous literature review drug safety