Analytical Solutions Tailored for You
At Goldfish Analytical CMC Consulting, we offer a comprehensive suite of analytical services designed to support your pharmaceutical development journey. From early-stage development to commercialisation, we provide expert guidance and solutions to ensure the success of your product.
Phase Appropriate Analytical Strategy & Gap Analysis
Goldfish Analytical CMC can develop tailored phase-appropriate analytical strategies to your specific needs, ensuring that your analytical methods are fit-for-purpose at each stage of development. We can also perform gap analyses for each drug development stage. Our approach is designed to be efficient and cost-effective, while maintaining the highest standards of quality.
CDMO/Contract Testing Labs Selection, Tech Transfer and Management
Our expertise helps you streamline your outsourcing activities and minimise risks. Goldfish Analytical CMC assist in the selection and management of CDMOs and CTLs ensuring that they meet your quality standards and regulatory requirements, including providing guidance in tech transfer of methods to your provider. We are also happy to provide guidance in due diligence and audit activities.
Stability
Goldfish Analytical CMC will manage all aspects of stability management for pharmaceutical products to ensure full compliance with ICH guidelines and international industry standards. The service includes tailoring stability studies for your pharmaceutical product.
Specifications
Goldfish Analytical CMC will maintain and monitor DS/DP and stability specifications helping to ensure these are fit-for-purpose.
Team Management
We provide flexible solutions for both interim and permanent team management, ensuring your organization has the leadership and support it needs at every stage.
Assay Qualifications and Validations
Goldfish Analytical CMC can help manage and guide qualification (also known as pre-validation) and validation of your analytical methods to ensure ICH guidance is met.