Semi-Solid Full Expertise.
Pharmaceutical contract manufacturing in Berlin.
We specialise in the manufacture of semi-solid dosage forms. With modern production facilities at our Berlin site and many years of pharmaceutical expertise, we offer customised solutions for creams, ointments, gels and suppositories. As an independent family-owned company, we stand for quality, reliability and discretion – building on strong partnerships and long-term relationships.
Tailored to your needs. Reliably supported.
From technical transfer through to market release, we provide all key services across the manufacturing process from a single source. Our areas of expertise are seamlessly integrated, ensuring the safe, efficient and collaborative implementation of pharmaceutical projects. Our full-service approach includes the following areas.
Manufacturing
We reliably manufacture semi-solid dosage forms across a wide range of batch sizes. Batch volumes from 200 to 2,000 litres for creams, ointments, pastes and gels, as well as up to 500 litres for suppositories and ovules, enable us to respond flexibly to a wide variety of requirements.
- Manufacture of medicinal products and medical devices
- Creams, ointments, pastes and gels up to 2,000 L, as well as suppositories and ovules with batch sizes of up to 500 L
- Manufacture of hormone preparations taking into account substance-specific PDE values and defined exposure limits
- Explosion-protected production and manufacturing under a nitrogen atmosphere possible
Filling and Packaging
Across four packaging lines, we fill tubes as well as suppositories and ovules. Flexible processes and a range of packaging solutions enable us to meet your specific requirements efficiently and reliably.
- Filling into aluminium tubes in various formats, e.g. stand-up tubes with fill volumes from 10 g to 100 g
- Primary packaging for suppositories and ovules made of aluminium or plastic foil
- Secondary packaging, including serialisation and aggregation, available
- Filling into Intermediate Bulk Containers (IBCs) with volumes from 50 L to 1,000 L
- Automated feeding of various inserts and application aids available
- Additional packaging formats available flexibly upon request
Quality Control
Chemical, physical and microbiological testing ensures that your products reliably meet the defined quality requirements.
- Comprehensive chromatographic analysis (HPLC, GC, TLC)
- Spectroscopic testing methods (UV/Vis and IR spectroscopy)
- Wet-chemical and physical testing methods (viscosity, penetrometry, pH, density and refractive index)
- Titration methods, including Karl Fischer titration and assay determination
- Particle size analysis using laser diffraction
- Microbiological testing in collaboration with a certified testing laboratory
- Stability testing in accordance with ICH guidelines, including long-term and accelerated stability studies
- Biochemical methods, including ELISA and flow cytometry
- Method development, validation and optimisation in accordance with ICH Q2(R1)
Tech Transfer
- Flexible adaptation and scaling of batch sizes
- Targeted process optimisation and systematic assessment of critical process parameters (CPPs)
- Guidance on process validation strategy
- Modern process validation in accordance with current regulatory requirements
- Product lifecycle management, e.g. ongoing process verification (OPV), implementation of alternative API sources and process design optimisation
- Formulation support, e.g. using process equipment on a laboratory scale
- Supporting analytical methods, e.g. digital 3D microscopy, viscosity and rheology measurements, spreadability and density determination, as well as Differential Scanning Calorimetry (DSC)
Regulatory Affairs
- Preparation and maintenance of regulatory dossier updates, including Modules 2.3 and 3, eCTD packages and well-founded justification documents
- Support in responding to regulatory deficiency letters
- Development of regulatory transfer plans
- Regulatory impact assessment of changes
- Preparation and maintenance of artwork documentation
Experience Production. Discover Our Expertise.
Certified Quality. Reliable Processes.
Quality and compliance are key success factors for our partners. Through certified processes and regular audits, we create the foundation for safe and reliable collaboration.
