Clinical Supplies
Services
http://www.clinical-supplies.de/services.php

© 2012 Clinical Supplies

Services

Our experience covers the following activities

  • Purchasing
  • Manufacturing
  • Label processing
  • Batch certification
  • Packaging
  • Blinding
  • Labeling
  • International distribution of clinical trial samples

Manufacturing in accordance with Manufacturing Authorisation § 13 Par. 1 AMG (German Drug Law)

  • Production of non-sterile dosage forms, primary packaging, blinding, labelling of Investigational Medicinal Products (IMPs) for clinical studies (Phase I to III)
  • Secondary packaging and labelling of IMPs for clinical studies (Phase IV)
  • Secondary packaging and labelling of licensed drug products (trading goods)
  • Manufacturing of medicinal products for compassionate use programs (see Manufacturing Authorisation)
  • Packaging and labelling of investigational veterinary drugs for clinical trials in animals
  • Qualified persons are permanently available to release investigational new drugs for distribution

Through the manual production of even the smallest batches, we guarantee you most possible flexibility.


Import of investigational medicinal products according to §72 Par. 1 AMG (German Drug Law)

  • Import of clinical investigational products from third countries (outside Europe)
  • Import of commercial trading goods, to be used in clinical studies as reference products (IMP).
  • Organisation of distribution & transport of the trial samples to European countries
  • EU-QP GMP certification for successful import to the EU
  • Audits of/at non-European pharmaceutical producers
  • EU-QP Declaration for submission of study approvals

Storage and Distribution

  • Temperature controlled / monitored storage
  • Inventory management
  • Worldwide shipment of clinical trials samples
  • Supply/dispatch of Investigational Medicinal Products to study subject’s homes directly (DTP)
  • Temperature-stabilized and monitored transports of different temperature ranges
  • Monitoring and documentation of transport conditions using temperature recorders
  • Processing, documentation, reconciliation and storage of returned trial medication

Services and Support

  • Purchase of EU trading goods as reference products, accompanying medication or rescue medication (refer to wholesale permit)
  • Expert advice on the preparation for clinical studies with regard to production-specific issues
  • Developing and writing of Pharmacy Manuals
  • Planning of demand, suggestions and purchase of suitable packaging materials
  • Many years of experience in reconstituting of IMPs for clinical trials (in compliance with the pharmacy operating license)
  • Storage of retaining samples and reference samples in accordance with EU or FDA legal regulations - in compliance with the specified storage conditions
  • Professional destruction of investigational products with destruction certificate (also of cytotoxic products) according to official / national regulations