Development
Whether product transfer or galenic development of pharmaceutical formulations, we are a service-oriented company with six development centres. As a result, we can offer formulation and process development as well as production of clinical trial samples and upscaling of pilot batches to industrial scale, including process validation. The group has corresponding analytical laboratories, which perform all manner of services relating to analytical method development and validation, method transfer and stability testing.
The connection with the in-house development for Aristo Pharma, means that at least 40 new development projects are carried out within the group of companies, each of which is conducted by qualified project managers. Our project managers are not only experts in their field, they are also our customers’ primary point of contact for all issues concerning development projects.
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Formulation development
Formulation development is the cornerstone of a new pharmaceutical product in every development project. Our expertise in this area includes:
- Selection and qualification of suitable suppliers
- Comparative studies
- Manufacture and selection of a wide variety of pre-formulations
- Characterisation of the originator product and presentation of generic formulations
- Patent research
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Upscaling and process development
After determining suitable product formulas in formulation development, the next step is to establish an efficient and cost-effective production process for the manufacture of a new product. By establishing different batch sizes, we can offer a product-specific process for commercial production for your needs. This step also includes manufacture and packaging of bioequivalence and clinical batches. Successful product development concludes product development and ensures products can be manufactured on a commercial scale.
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Analytical services/stability studies
Our formulation and process development is highly efficient owing to the close integration of production and analytical laboratory, thus creating a decisive time advantage in the development phase. In addition to the location-based laboratories, we also have an additional laboratory for contract analysis at our disposal that allows us to execute corresponding orders on schedule. All our laboratories are equipped with experienced and professional teams and the latest analytical equipment. Our expertise in this area includes:
- Analytical method development
- Analytical control of raw materials, bulk and finished products
- Stability storage and testing
- Management of efficient process development and upscaling
- In-vitro and in-vivo release
- Analytical method development
- EU reanalysis
- Market release
Manufacture
Owing to the wide range of services within our six GMP certified factories, we are able to offer manufacture and packaging of a wide range of different dosage forms and special products.
Our focus is on customer satisfaction, good customer service, quality in accordance with specifications and on-time delivery. This allows us to provide a reliable and needs-driven market supply at any time.
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Technologies, forms and special products
An overview of our technologies, forms and special products:
- Tablets
- Coated goods
- Effervescent tablets
- Multi-particulate forms
- Capsules
- Sachets/stick packs
- Cephalosporins
- Hormones
- Semi-solids
- Liquids
- Narcotics
- Packaging
Out-licensing
In addition to product development and transfer of the manufacture of pharmaceutical products, our service portfolio also includes out-licensing of our own products to partners all over the world.
We would be happy to share a list of the different products with you! Get in touch and tell us what you want.
Logistics
To cover the entire supply chain, you have the option of professionally storing your finished products with us and having them shipped in accordance with Good Distribution Practice (GDP-compliant) standards. This service covers the whole of Germany, Austria and countries that can be reached by lorry within 24 to 48 hours.
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Incoming goods/storage
In accordance with our industry standards, all products are inspected for integrity, product and batch identity, expiration dates and quantities upon receipt of goods. In the case of mixed pallets, the products are repacked in single batches to avoid mix-ups in our warehouse.
Once the goods have been accepted, they are stored in the various storage areas, depending on the specifications. We have sufficient storage capacity both for temperatures from 15°C to 25°C and from 2°C to 8°C. Storage of sensitive substances such as cytostatic drugs can also be carried out safely and in accordance with the regulations.
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Order picking
Our standards of quality and cost-efficiency in the manufacture of pharmaceuticals and shipping are high, thus ensuring a professional delivery service. Once your orders have been received in the warehouse management programme, volume calculation allocates them to the appropriate packaging units.
State-of-the-art picking technology reliably guides the order picker through the processing of your orders. By using barcode scanning on all products and quantities to be delivered, we can check that all orders are distributed as required.
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Returns handling
We offer a customised returns handling process according to your wishes and requirements.
In the event of recalls, as your partner, we can also handle the entire process for you – quickly and reliably.
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Repacking
The GMP area adjacent to the warehouse and logistics area gives our distribution site a special advantage. It gives us the necessary flexibility to quickly respond to changing market conditions or requirements by the authorities. In addition, we can offer professional assistance with our own manual packaging department to ensure short-term availability of your goods on the market.