Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Quality control

In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

Drug development
Small batches & clinical trial products

Manufacturing of small to medium sized batches

We are specialised in the Manufacturing of clinical trial medication and small market batches under GMP conditions.

Small and clinical trial batches

In addition to our many years of experience, we also have a wide range of technological and analytical equipment for the development, manufacture and characterisation of medicinal products. Besides conventional manufacturing processes, we also offer innovative technologies to meet the challenges of new active substances. Nanotechnology in particular represents a focus within these innovative technologies.

For registered products, we take care of the manufacturing, labelling, packaging and serialisation of small and medium batch sizes.

You can find out more about our automated and validated serialisation process here: Flyer serialisation

Our services

Solid dosage forms

Manufacture of oral solid dosage forms up to approx. 75 kg batch size
Manufacture of granules, direct blends and filling into capsules
Manufacture of granules, direct blends and processing into tablets and film-coated tablets
Manufacture of pellets and filling into capsules
Manufacture of meltable tablets (ODTs)
Manufacture of buccal tablets
Flavour masking
Primary packaging of tablets, capsules in blisters or bottles

Semi-solid and liquid dosage forms

Manufacture of semi-solid and liquid products up to approx. 100 kg batch size
Manufacture of solutions
Manufacture of micro- and nanosuspensions via wet milling (bead milling) or high-pressure homogenisation (HPH)
Manufacture of emulsions and self-emulsifying systems (SEDDs, SMEDDs)
Manufacture of lyophilisates
Filling of liquid products in vials, bottles and syringes
Filling of semi-solid products in bottles, tins, syringes and tubes

Packaging and serialisation

Customised primary and secondary packaging
Procurement of packaging materials (labels, folding boxes, package leaflets, etc.)
Serialisation (TraceLink)
Security features (e.g. tamper-evident labels)

Clinical trials manufacturing