Laboratory services
Laboratory services
We are your partner for pharmaceutical analysis and quality control.
Analytical services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-release analysis, stability testing and structure determination of unknown substances, our core expertise also include risk-based and solution-oriented customer consultation.
More than 45 employees work in our analytical labs, supported by lean management tools, to specifically and efficiently meet the requirements of our clients. Our interdisciplinary teams and professional project management ensure even your complex projects are a success.
HWI is GMP- and FDA-certified and holds a manufacturing authorisation for the release of clinical and market batches.
Consultation
The HWI team works on the basis of current regulatory requirements for human and veterinary medicinal products as well as for substance-based medical devices and drug-device combination products.
We provide support and advice on analytical and associated regulatory matters:
Review specifications, analytical methods and validation reports according to the latest scientific knowledge and regulatory requirements
Planning and implementation of analytical method transfers and production validations
Gap analysis of CTD modules 2.3/3 together with further experts in the HWI group from HWI regulatory services GmbH and HWI development GmbH
Active ingredients and excipients
We test active ingredients and excipients according to the latest monographs of European Pharmacopoeia and USP as well as other pharmacopoeias on request. For new active ingredients and excipients we develop and validate analytical methods to test for content and purity using cutting- edge analytical equipment. Highly potent active ingredients or narcotics can also be tested in our laboratory after prior verification of the situation.
Ready-to-use products
Our laboratory team of more than 45 members of staff has long- standing experience in developing and validating test methods and the use of these methods for different dosage forms in the quality control of medicinal products.
As part of developing test methods we place special attention on sample preparation to make sure this is efficient and robust. Our experience includes the most diverse complex matrices such as semi- solid and prolonged- release formulations.
Our technical equipment, regulatory expertise and strong team enable us to investigate products with chemically defined active ingredients as well as herbal and biotechnologically produced active ingredients.
Medical devices
We are specialised in the analytical testing and quality control of substance- based medical devices and drug- device combination products, and can draw on our extensive experience in various projects over the past few years.
We develop and validate test methods for identity testing, assay, purity testing and the release of active pharmaceutical ingredients in combination products in accordance with national and international guidelines. As part of the quality control of substance- based medical devices and drug- device combination products, we conduct analytical tests for batch release and shelf life according to defined specifications.
We offer physical–chemical characterisation concepts that are individually tailored to your product and perform the relevant extraction studies in our lab. These are for the tests required according to ISO 10993 as part of biocompatibility requirements.
