Working to ICH and cGMP guidelines, we provide analytical support for a wide variety of product development programmes. With an extensive range of fully qualified analytical equipment available as well as comprehensive stability studies expertise, we work closely with our clients to assist every stage of the product development cycle.

We will apply our expertise and detailed understanding of all relevant regulatory requirements, including the EU Clinical Directive, to ensure that your development programmes are professionally and accurately supported. Our competence in this specialist area provides you with the benefit of data and documentation necessary for product accreditation.

Our expertise and flexible client orientated approach provides you with:

• Stand alone analytical services
• Support Formulation Development activities
• Development and validation of methodologies
• Supply and execution of method transfer protocols
• The establishment of new product assay and degradation methods within appropriate ranges
• Upgrades to your old analytical methods to current standards, with appropriate validation
• Options of graduated validation plans to suit the current phase of your drug development
• An extensive range of fully qualified equipment
• European testing facilities and Qualified Person release for non-EU products
• Stability indicating assays in accordance with specific protocols
• Stability facilities and capacity to accommodate a range of ICH conditions
• Extensive experience of dealing with regulatory dossiers
• Expert regulatory documentation for regulatory submissions worldwide to assist you in avoiding common regulatory pitfalls and minimise any potential delays.