Andrew Thomson is a Senior Analytical Consultant at GreyRigge Associates (GRA) with over 25 years of pharmaceutical industry experience, serving as a specialist biopharma consultant since 2005. He focuses on three core strategic areas: the qualification, validation, and tech transfer of complex analytical methods; establishing robust stability testing programmes under cGMP compliance; and providing embedded Quality Person-in-Plant oversight for advanced parenteral therapeutics, including Antibody-Drug Conjugates (ADCs) such as Adcetris and Trodelvy. Andrew also played a key role alongside bioProcessUK and the Knowledge Transfer Network (KTN) to establish the UK’s Analytical Development and Formulation Working Groups.
Expertise: Primary Service Skillsets
Assays & Quality Control
Andrew offers extensive technical leadership in designing, validating, and troubleshooting analytical control strategies for drug candidates at every stage of clinical and commercial development.
- Method Qualification & Validation: Directing the phase-appropriate qualification and validation of analytical methods and equipment in strict accordance with ICH guidelines.
- Analytical Technology Transfer: Leading cross-border method tech transfer protocols between sponsor laboratories, testing facilities, and commercial sites.
- Investigational Support: Providing expert root-cause analysis and resolution for Out of Specification (OOS), Out of Trend (OOT), and analytical deviation events during regulatory submissions.
Formulation Development & Stability
His analytical background underpins a deep operational capability in setting up and managing data-driven stability and formulation programmes for parenteral products.
- Stability Study Setup: Designing and managing comprehensive stability study protocols to evaluate shelf life, force degradation, and product comparability.
- Parenteral Product Analysis: Evaluating formulation integrity and analytical profiles for complex modalities, including bioconjugates and liquid/lyophilised parenterals.
QA, Auditing & Regulatory Affairs
Andrew integrates analytical rigour directly into quality management systems and operational facility oversight.
- Quality Person-in-Plant: Serving as a dedicated, on-site technical representative to oversee active manufacturing, analytical testing, and batch release workflows within cGMP environments.
- Quality Management Systems (QMS): Establishing, auditing, and maintaining robust Quality Management Systems, performing quality audits for contract facilities and QC laboratories.
- Regulatory Submissions: Authoring and reviewing analytical, stability, and quality control sections for global regulatory filings with the MHRA, FDA, and EMA.
Additional Technical Specialisms
To ensure comprehensive support across the full product lifecycle, Andrew also provides expert consultancy across these core GRA service areas:
- CDMO & CRO Oversight: Managing analytical workflows, laboratory testing, and technical communication with external contract testing facilities.
- Technical Due Diligence: Evaluating analytical control strategies, validation packages, and laboratory compliance data for asset evaluations and transactions.
- Industry Community Leadership: Setting up and running specialist interest groups, expert conferences, and collaborative networks across bioProcessUK, KTNs, and BioProNET.
If you would like to discuss your project with Andrew Thomson or require specialist advice, please get in touch.
