Clinical & Regulatory Support
Polymun has organised many clinical studies in various indications over a period of more than 20 years. This expertise is now available as service for our customers.
IMPD / IND Preparation
As part of our GMP production service, Polymun authors the quality data section of the IMPD (Investigational Medicinal Product Dossier: basis for approval of clinical trials by the competent authorities in the EU) or IND (Investigational New Drug Application: request for authorization from the US Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans), respectively.
We also offer the preparation of the other sections of IMPD documents (nonclinical and clinical data) as well as the preparations of Investigator's Brochures in cooperation with our customers.
In addition, we offer the compilation of documents for IRBs / ECs (Institutional Review Boards / Independent Ethics Committees).
Pre-/ Clinical Development Concepts and Scientific Advice
We help you to develop concepts for preclinical and clinical study programs which ensure fastest regulatory approval of your product.
We offer the selection of preclinical research organisations that meet your requirements and the coordination of toxicity, pharmacokinetics, and pharmacology studies.
We help you with the preparation for Scientific Advice including document preparation, submission and discussion with the relevant regulatory authorities.
Organisation of Clinical Studies
We offer the overall coordination and management of clinical studies or of individual parts of a study. Polymun's project manager keep you updated about every step of the process. Individually offered modules include the preparation of documents for submissions to the relevant authorities and concerned IRBs (document preparation, submission, response to queries), selection of clinical sites and specific analytical laboratories, selection and management of local CROs, handling and transport of study medication and analytical samples.
The EU Clinical Trial Directive (2001/20/EC) requires every sponsor conducting a clinical trial in the European Union (EU) and not having a registered office within the territory of the European Economic Area (EU plus Norway, Iceland & Liechtenstein) to have a legal representative located in one of the EEA countries. This requirement applies to all clinical trials conducted with medicinal and/or pharmaceutical products as well as medical devices.
A legal representative acts as the agent of a sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA.
Polymun can be your legal representative in Europe to ensure that your company complies with the above requirements.
- IMPD / IND, IRB Submission
- Pre-/Clinical Development Concepts and Scientific Advice
- Organisation of Clinical Studies
- Legal Representative