Pharmaceutical contract manufacturing
Contract manufacturing means that we produce products for you on your behalf – drawing on our expertise, precision and the highest quality standards. It is precisely when things get complex that our strengths come into play: small batch sizes, aseptic manufacturing, flexible processes and a deep understanding of regulatory requirements.
We support your project
Are you faced with the challenge of bringing highly specialised products to market under economical conditions and within a tight regulatory framework? This is exactly where we provide support: with a network of qualified active ingredient manufacturers, suppliers and transport partners, with our own warehousing and refrigerated logistics and, if required, including order picking.
Our particular strength lies in solving complex manufacturing tasks - because we don't shy away, but place the therapeutic benefits of a medicinal product above the technical challenge.
Challenge us - we look forward to your enquiry!
Cooperation in contract manufacturing
The first step in contract manufacturing? Getting in touch with us. We start directly with a joint non-disclosure agreement - so that you can count on confidentiality right from the start. We then exchange the most important documents and check whether your project can be realised with us.
Based on this assessment, we draw up a letter of intent (LOI): with a concrete price estimate, project costs and an initial schedule. As soon as you agree, we get started - together with an experienced team that will guide you transparently through the entire process.
Because for us, genuine collaboration is part and parcel of contract manufacturing. And of course: the project only ends for us when you have your positive approval notice in your hands.
Our services in contract manufacturing
We have been supporting national and international pharmaceutical companies in the manufacture and authorisation of their veterinary medicinal products for decades. Above all, our customers value our ability to flexibly realise individual requirements - from individual services to full service. Whether galenic development, production, documentation or authorisation: we offer customised solutions that are precisely tailored to your product and your market.
We are happy to support you with the following challenges:
- Project management for your pharmaceutical production
- Formulation development and optimisation
- Narcotics storage and dispatch
- Production of pilot batches on a small scale
- GMP-compliant production
- Final release for the marketing of contract manufactured medicinal products in accordance with TAMG / TAMWHV
Realisable batch sizes
- Sterile solutions (200 l-600 l)
- Suspensions (150 l-600 l)
- Ointments (100 kg-300 kg)
- Non-sterile solutions and gels (200 l-1000 l)
Services for compliance with regulatory requirements
We provide our clients in the veterinary sector with comprehensive support in the authorisation of medicinal products in a wide variety of dosage forms (e.g. injection solutions and suspensions, semi-solid and solid forms), particularly with regard to the preparation and assessment (expert report) of chemical-pharmaceutical documentation (Part II), including all method validations and stability tests and storage in accordance with ICH/VICH. The processing of any complaints is of course included here.
- Process validation
- Development of test methods and validation of analytics
- Stability tests according to ICH/VICH
- Physical, chemical-analytical and microbiological tests and evaluation of the results
- Preparation of the annual PQR
Referentin für die pharmazeutische Herstellung
Leitung Projektmanagement