Analytical Chemistry

We offer tailored services to our customers for every phase of the product life cycle. With our specialized teams, we support you with a full complement of analytical services from method development, transfer, validation to ICH-compliant stability tests. We understand the value of an upfront in-depth understanding of key points such as reaction profiles and the quality and physical form of starting materials, intermediates and the final product. Our analytical services support new products through the life cycle and includes supporting route scouting and process development activities and accelerates your development program, we provide a comprehensive range of analytical services.

Method Development and Validation

Our analytical development and Quality Control teams have in-house access to a comprehensive range of state-of-the-art analytical techniques and extensive experience in development and validation of analytical methods. Operating from our purpose-built modern laboratories our analytical and quality control teams offer a full range of services providing scientifically robust data you need for regulatory submissions and to guide your next steps.

Our teams develop methods to analyse the identity, strength and purity of products and raw materials, as well as developing stability indicating methods. We operate with state-of-the-art technology to support our innovative approaches to achieve best results and development capabilities. We have a life cycle approach to method development and routinely develop methods applicable throughout the life cycle of the product.

We also provide analytical validation in compliance with the European Pharmcopoeia (Ph. Eur) the US Food and Drug Administration (US FDA), current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) requirements.

Solid State Analysis

Our expert solid-state knowledge is multidimensional, facilitating a complete solid-state package for a successful project development. Besides our state-of-the-art material support we also offer a decisive regulatory and IP experience as well as a unique inhalation know how. Our combined competence covers the whole range from early discovery phase up until and including marketed products.

This includes material understanding studies of a given material, compound or just a specific batch, which is key to successful final outcome of any development project. The results from general solid-state characterization are the foundation to base decisions on e.g. handling conditions, process possibilities or perhaps to initiate a search for a better solid form.

Stability Studies

As part of our services we provide cGMP compliant stability testing services. We operate and carry out stability studies according to ICH stability testing. We provide solutions to suit all our customers, including early development through to final manufacturing for all products, intermediates, starting materials. Our team are experts in devising and complying with detailed stability plans and rep0orting to support your product.