We offer our services as experts.
We produce expert reports, meta-analyses and microbiological resistance reports, respond to deficiency letters, and support you in developing product information (SPCs) or brochures.
Expert reports for the marketing authorisation of medicinal products
In terms of both content and formal requirements, the reports are produced in accordance with the current expectations (Notice to Applicants [NTA]) and your preferences.
We take both your own preclinical and clinical studies as well as the results from a detailed literature search into account.
The documentation is delivered either as a hard copy or electronically, ready for electronic submission.
Report on biological and clinical assessment of medical devices
We primarily assess 'substance-based medical devices', also distinguishing them from cosmetics and medicinal products. We heed the latest international and national formal and content requirements (notified bodies for medical devices, TÜV in Germany).
The documentation on your medical device will be compiled on the basis of your own data or clinical studies, as well as a literature search.
The report on biological assessment describes the preclinical safety of the product, whereas the report on clinical assessment covers the efficacy and safety of the medical device when used in humans.
The assessments and documentation are delivered on paper and/or electronically.
Response to questions and deficiency letters from authorities or notified bodies
We also offer the following special services:
- Meta-analysis concerning the efficacy and safety of medicinal products
It is not always easy to analyse published clinical studies and draw conclusions on the efficacy and safety of your medicinal product, because the quality of the studies or publications can be very varied.
We offer you the opportunity to consolidate the published data in meta-analyses and evaluate the data. In doing so we use the statistical methods developed by the Cochrane Collaboration.
- Environmental risk assessment
- Resistance reports on antibiotics
We can write resistance reports on antibiotics and make proposals concerning the table to be included in the summary of product characteristics.
We offer such reports independent of expert appraisals.
- Scientific information for experts and medical laypersons
We can write your product information (SPC), package leaflets, publications and brochures, and also help you to train your sales representatives.