Development

Galenic development of sterile, solid and liquid dosage forms

All development work is conducted in accordance with current guidelines and
legislation. We offer complete development comprising formulation development, process development and scale-up for market supply. Our development concepts aim a high quality for a reasonable cost.

We have specific experience with regard to sterile forms such as ampoules and cartridges. Easy of use of cartridges is ensured by the availability of a wide range of application devices.

Another important field is the development of solid dosage forms

• Immediate-release tablets
• Tablets with functional coating
• Sugar-coated tablets
• Pellets

For your market-oriented products, we are familiar with ODTs and chewable tablets. We develop granulates for improved oral application, including stick packs.

The development of oral liquids is accompanied by the perfect choice of containers and dosing devices for adults and especially children (PIP). We also have extensive experience in tast-masking and flavouring of oral forms.

Market-oriented development of topical liquids completes our portfolio.

Efficient product transfer

Meeting the marketing needs of our customers is our primary goal. Quality through goal-oriented and market-driven design ensures efficient use of development and transfer times for smooth implementation.

Your formulation or individually designed process will be implemented in the shortest time possible. Associated measures including validation work are strong components of our transfer process and also ensure shortest time-to-market.

Transparent and reliable project management

Transparent project management from the first request up to finalisation.
We support your project from concept to market. You will have a dedicated contact person to take care of all aspects of your product throughout the process.
By means of appropriate communication tools we will actively keep you informed at all times about the status of your project.
If other external partners are involved in the project, we will readily take care of coordination as well. 

Development and validation of analytical methods and conduct of special tests

To test your pharmaceutical products, we develop and optimise  analytical methods for determining identity, content, purity and dissolution using UV, DC, HPLC and GC.

We validate the methods as well as client´s methods in accordance with the
applicable ICH guidelines. Outsourced activities for special investigations such
as AAS or LC-MS are coordinated to complete our service portfolio for you.

Stability testing in accordance with ICH

We provide storage for stability testing and conduct stability testing of tablets, capsules, solutions and small volume parenterals with the international regulations.

In line with the shelf life specification, we investigate the quality parameters such as content, purity, dissolution, physicochemical properties, eg., using standard methods such as HPLC, GC, DC and UV.

Furthermore, we can perform your photostability and in use stability testing.

On the basis of the results, we provide you with suggestions for the preparation of specifications as well as for optimising your processes and formulations

Dossier compilation and management

We produce the quality-related parts of the registration dossier in accordance with current requirements. This may be first-time documentation (e.g. following product development in-house), or it may be an update of an existing product registration or involve changing the format from NTA to CTD.
We support you during the whole registration process, provide rapid support if you receive notice of regulatory deficiencies and assist you in regulatory compliance projects.