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.

Development

The active ingredient is at the heart of our risk-based formulation development. Its properties have a critical influence on the quality of the product. In our ultra-modern clean rooms we can also work with highly potent active ingredients. By using statistical design of experiment (DoE) we offer an efficient pharmaceutical development that completely fulfils the requirements of quality by design.

Drug development

Development
Pharmaceutical technologies

Pharmaceutical technologies

In addition to conventional manufacturing processes we also offer innovative technologies to meet the requirements of new active ingredients. Nanotechnology is a particular focus within these new technologies.

Customised solutions

We offer customised solutions for your product and develop the necessary prototypes in the initial development steps and a robust formulation for the clinical development.

Our technologies

Conventional technologies (oral application)

Production of granules, direct blends and filling in capsules
Production of granules, direct blends and processing into tablets and film-coated tablets
Production of pellets and filling in capsules
Production of ODTs
Production of buccal tablets
Production of solutions and microsuspensions including taste masking
Primary (bottles, blister packs, containers) and secondary packaging of tablets, capsules, solutions and suspensions

Parenteral technologies

Production of sterile solutions, microsuspensions and emulsions (via high-pressure homogenisation) and aseptic filling in vials, bottles and ready-to-fill syringes
Production of lyophilisates
Visual check, primary and secondary packaging

Innovative technologies

Production of sterile nanosuspensions for parenteral, nasal and topical application
Production of PLGA-based sterile microparticles
Production of sterile hydrogels/oleogels for nasal application
Production of sterile hydrogels/oleogels for inner-ear application
Production of adhesive mixtures and filling in inhalation devices
Assembly of filled ready-to-fill syringes in PEN devices
Visual check, primary and secondary packaging