Our experts take innovative therapeutic approaches from conception to market launch. As a CDMO, we also develop and manufacture for our customers on a contract basis. Our services include formulation development and manufacture as well as analytical method development and characterisation for for solid, semi-solid and liquid medicinal products.
We focus on the development and manufacturing of small to medium-sized batches of different dosage forms for oral, topical, nasal and parenteral use. In our clean rooms we are able to work with high potent active ingredients (up to OEL4 / OEB 5) as well as with substances of high or unknown toxicity. Interlinked formulation development, analytical testing and regulatory services within HWI group enable us to offer drug development as a complete package or in individual modules.
Drug development services include:
- Development of new drug products
- Development of innovative products for poorly soluble active ingredients or new applications
- Optimisation and reformulation of existing products
- Generic developments
- Development of herbal medicinal products
- Analytical method development and validation
- Manufacturing, primary and secondary packaging, release testing and release as well as distribution of clinical trial medication
What is drug development?
Drug development involves the chemical and physical characterisation of the desired active substance, development of a suitable formulation, analytical testing, upscaling of the formulation to production scale, and pre-clinical and clinical testing. This is a complex and multi-stage process aimed at developing and producing safe and effective therapeutics for human use.
What are the phases of drug development?
Drug development is divided into different phases in which efficacy, safety, tolerability and dosage are tested. These include the pre-clinical phase and clinical phases 1 to 3.
Who approves clinical trials?
In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute are responsible for approving clinical trials. In addition, a favourable opinion from an independent ethics committee is usually required to protect the rights, safety and well-being of trial participants.
How are clinical trials carried out?
Clinical trials are conducted in several phases, each with specific objectives and methods. They may be randomised, placebo-controlled and double-blind to ensure the objectivity and validity of the results.
How long does it take to get a medicinal product approved?
On average, it takes 10-15 years from the discovery of an active ingredient to the approval of a medicine. If a known compound is used in a new medicinal product to be developed, this time is reduced.
What is the difference between a CDMO and a CMO?
In the pharmaceutical industry, a contract manufacturing organisation (CMO) is a contract manufacturer that produces various intermediate products of a medicinal product or the final product on a contract basis.
In addition to manufacturing a product, some companies also provide support in research and development, formulation development and other analytical and pharmaceutical areas. These companies are called contract development and manufacturing organisations (CDMO) or contract manufacturers and developers.
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