Clinical Trial Materials CTM

Temmler has more than 20 years of experience in the manufacturing, packaging, blinding, labelling and distribution of investigational medicinal products.

All established solid, semi-solid and oral pharmaceutical dosage forms including non-sterile liquid forms are manufacture in our GMP areas as investigational medicinal products, from lab scale to production scale for Phase 1 to Phase 4 clinical studies.

An independent division of the company attends to the special requirements of clinical study designs with regard to packaging, blinding and labelling of clinical trial design. Our fully equipped department is able to offer a wide range of primary packaging systems (blister packs, seal bags made of aluminium, sachet filing, bottle filling with/without induction seal), blinding processes (blisters containing different dosages/products, blister cards, tube-in-tube blinding) and secondary packaging (adapted designs with/without printing) for clinical trials. Temmler offers various flexible solutions for the labelling according to Annex 13 (with/without randomisation), including multilingual panel labels and booklets as well as extremely flexible monolingual labels which are printed and applied by the clinical trials centre only after the order has been received (delivery within 1 week after the order has been received).

Temmler distributes clinical trials within and outside Europe in close cooperation with qualified transport companies via its logistics centre and data bank. The range of activities also includes batch tracking, cold chain distribution and the destruction of returned study medication.

Qualified persons are available for the release of study medication in compliance with Annex 13 as well as the evaluation of the quality systems of suppliers and, for example, third country manufacturers.

The Close network of our Development, Clinical Trial Materials and Production departments with the same GMP environment ensures consistent top level quality and continuous state-of-the-art service during the planning and preparation of your clinical trial products through all clinical phases.

In addition, our network with other CROs offers you further services such as the planning and implementation of clinical trials (all phases) and bio-analytical testing in full compliance with GLP guidelines.