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 Lifecycle Strategy & Gap Analysis
Goldfish Analytical CMC designs and implements phase-appropriate analytical control strategies aligned with regulatory expectations and the specific requirements of your development programme. We ensure analytical methods are scientifically justified, validated as appropriate for phase, and demonstrably fit-for-purpose across the product lifecycle. In addition, we perform detailed gap analyses against current FDA and EMA guidance to identify compliance risks, support regulatory readiness, and enable robust control strategy development. Our approach integrates efficiency and cost-effectiveness with a strong emphasis on data integrity, method robustness, and regulatory compliance.
CDMO/Contract Testing Labs Selection, Tech Transfer and Governance
Goldfish Analytical CMC brings a dual perspective shaped by extensive experience both within sponsor organisations and in central testing laboratories. This allows us to provide practical, risk-based support in the selection and management of CDMOs and contract testing laboratories, ensuring alignment with quality standards, regulatory expectations, and programme objectives. We also provide experienced guidance on analytical method transfer, due diligence, and audit activities, helping to strengthen oversight, improve decision-making, and support successful outsourced operations.
Stability Programmes
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.