Intertek ASG Laboratory, Manchester, UK

Regulatory Packages

Intertek ASG offers Regulatory Package analytical and technical services for characterisation, development, verification, validation, stability, early clinical phase studies and more.

Intertek ASG can also provide specific packages for compliance with NONS / EU REACH legislation. For more information please visit:

• GLP Studies for NONS / REACH.

ASG capabilities can be deployed in regulatory submissions and product release analysis.

ASG has been a member of the UK GLP compliance programme since 1987 for the provision of chemical characterisation and physical, chemical data to support the worldwide registration and notification of new chemical products and intertmediates, including submissions to the US EPA and Japanese MITI regulatory agencies. A statement of GLP compliance, issued by the monitoring authority via their biennial inspection programme has been maintained since 1987. ASG also operates to cGMP.

Intertek ASG Regulatory Packages and Support Services:

• Characterisation of materials for use in toxicology studies
• Analysis Packages for CMC sections of INDs (USA) or CTAs (Europe) and their annual updates
• Detailed Characterisation studies for CMC section of NDA, including Critical Parameter Studies, protein characterisation, etc
• Development and verification of QC methods for release of early clinical phase APIs and formulated product materials
• Develpment and full Validation to ICH guidelines of QC methods for release of late clinical phase and launched products
• Method remediation and validation
• New Product Notification packages, such as OECD NONS Guidelines Annex 7, for chemical and pharmaceutical products and intermediates
• New Product Notification packages to EEC, EPA and MITI requirements
• More on ASG GLP, cGMP Quality Assurance
• Stability studies
• Extractables and leachables studies e.g. for the interaction and compatibility of drug products with packaging components
• Physical Property Measurements required for regulatory packages

asg.nwtc@intertek.com

+44 (0) 161 721 5247

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Email ASGlab@intertek.com for more information

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