Senior experts, not generalists.

John M. Sall, PharmD, PhD

John is a Regulatory Consultant with over 20 years of experience in achieving corporate objectives for a wide range of pharmaceutical companies around the globe. John's expertise lies in assessing, developing and implementing successful regulatory strategies for regional or global development plans of innovative small molecule and biologic therapeutics. He has helped clients assess potential assets by conducting thorough due diligence reviews, providing innovative regulatory strategies that utilize expedited regulatory pathways, and strategic guidance for correspondence with or meeting preparation for Health Authorities.

Lauren Workman, PhD

Lauren is a Global CMC regulatory affairs consultant with over 10 years experience in biopharmaceutical industry. Lauren specializes in regulatory strategy, CMC change management, compliance gap analyses, and risk mitigation for small molecule and biologic drug products. She has experience authoring IND/NDA applications and post-approval variations for global health authorities and acting as a CMC representative in cross-functional meetings with project teams, contract manufacturing sites, and other key stakeholders.

Su Yu, PhD

Su has over 20 years of experience in global CMC regulatory affairs and drug development and manufacturing. Her expertise lies in developing global regulatory CMC strategies in biologics, small molecules, gene therapy ATMPs and combination products with successful submissions across development stages including BLA/NDA, MAA, IND and IMPD, post-approval supplements and other global submissions. She has extensive experience in developing regulatory strategies for challenging CMC situations and creating high quality, compliant CMC regulatory documents. She has experience in therapeutic areas of oncology, immunology, CNS, chronic kidney disease and infectious disease.

Joy Gao, PhD

Joy has 26 years experience in Technical and Regulatory support for US, EU, China, and ROW. She brings a strong 10+ years CMC background from product research and development to manufacturing operations with an additional 16 years regulatory CMC biologics experience in mAbs, ADCs, biological products, and Cell Gene therapy products. Before moving to consultancy, Dr Gao was the Regulatory CMC Executive Director at Sanofi leading biological clinical programs, including development of regulatory CMC strategy for early phase Cell/Gene therapy pipeline projects and two Phase 3 programs with Orphan/Breakthrough therapy designation.

Sam Denby, PhD

Sam has deep technical expertise in all aspects of upstream bioprocessing for monoclonal antibody and cell and gene therapy products. Sam has helped companies transition from research to development; established, validated, scaled up and technology transferred manufacturing processes; provided industry and technical insight to the development of business strategy.

Brian Tham

Brian is a Senior CMC and Technical Operations consultant with 25+ years of experience delivering strategic and operational solutions across biologics, vaccines, and advanced therapies. Trusted by biotech executives and investors to de-risk development programs, enable regulatory success, and build scalable manufacturing strategies from early development through commercialization.

Ann Taylor-Hutchinson

Ann has over 30 years experience within the pharmaceutical industry within larger pharma companies, smaller biotechs and CDMOs. Ann's expertise lies in pharmaceutical development - analytical development and formulation selection, through process manufacturing strategy, outsourcing, new product introduction, technology transfer, and complex global program leadership. She has helped clients deliver clinical supplies, launch new products, establish internal systems, rationalize global analytical operations, and close out contracts.

Michael Howell, PhD

Michael is a drug product development leader with deep experience in formulation, process development, scale-up, and technology transfer across oral solid and sterile dosage forms, supporting programs from early clinical phases through registration and commercial supply.

Robert Leming

Robert advises clients on drug product manufacturing strategy, process robustness, and working with CDMOs to deliver reliable clinical and commercial supply, including tech transfer planning and execution.

Karen Lewis, PhD

Karen is a quality and CMC professional with strong experience supporting drug product programs, manufacturing partnerships, investigations, and the systems needed to maintain compliant supply.

Huizhen Zhang, PhD

Huizhen is a senior CMC Consultant and drug product development expert with nearly 20 years of experience advancing small molecule programs from early development to commercial launch. She provides technical and regulatory advisory support on product development, CMC risk management, and manufacturing strategy execution.

She has extensive experience across versatile dosage forms, with deep expertise in oral solid and sterile products. She has brought multiple MR tablets, an IR tablet, injectable, and ophthalmic solution programs to launch or launch-ready status, directed programs across pre-clinical and clinical phases, and authored CMC modules for IND, IMPD, NDA, and ANDA submissions.

Lydia Wright

Lydia is a Senior Quality Assurance professional with 30 years experience in the pharmaceutical industry. Lydia's expertise lies in her ability to create Quality Management Systems in accordance with FDA and international health agency requirements. She brings leadership and expertise in resolving start-up and ongoing quality issues, as well as overseeing the quality systems. Lydia's knowledge of start-to-end commercial manufacture and supply expanded through various managerial positions, including Microbiology, Analytical, supply chain, warehousing, and leading cross-functional project teams to transfer drug products, and Active Pharmaceutical Ingredients successfully.

David Shackelford

David has over 33 years of experience in the pharmaceutical industry with extensive experience in cGMP compliance related to the manufacture of Pharmaceutical products. This includes solid dose, aerosol, dermatological, liquid and encapsulated product types. His areas of expertise include Process/Product Validation, Quality oversight of Contract Manufacturers and cGMP compliance related to CAPA implementation and many other areas of pharmaceutical manufacture.

Cynthia Gronostajski

Cynthia is a Quality professional with demonstrated experience in global GXP (GMP/GCP/GLP) regulated environments and management of FDA Consent Decree activities. She has over twenty years of quality/compliance expertise and management experience primarily in the Pharmaceutical and Biotech industry. Experience includes quality assurance (GMP - FDA 210, 211, 820, Part 4; ISO 13485; ICH Q7-11 and EU Requirements; GCP - FDA 312, 50, 54-56, ICH E6 (R2); GLP - FDA 58), regulatory compliance/labeling, project management, clinical & commercial manufacturing, third-party contract manufacturing, team building & leadership, & training & development.

Mandy Cooke, PhD

Mandy is a quality assurance consultant with expertise in GMP systems, audits, CAPA and deviation management, and helping organizations remediate compliance gaps while keeping supply running.

Raj Parhar

Raj brings senior QA leadership experience spanning batch release, supplier and contract site oversight, quality agreements, and inspection readiness across pharmaceutical operations.

Diana McGeehan

Diana is a Graphic Designer specializing in logo and packaging development for pharmaceutical products. She has over 25 years of experience in packaging design and print development for pharmaceutical products. A solution-driven, customer-focused team member with a broad understanding of pharmaceutical packaging requirements, she has managed project timelines, communications, and resources from inception through launch.

Andy Grieves

Andy is a senior Pharma/Biopharma Operations Professional with 30+ years experience in leading pharmaceutical manufacturing sites, capital programmes, business transformation, manufacturing strategy and new product acquisition due diligence. Andy thrives in leading cross functional teams involving Commercial, R&D, Manufacturing and Corporate functions, utilising a collaborative and inclusive leadership style. He demonstrates the ability to 'join the dots' from development of strategic options, preparation of business cases, securing endorsement from C-Suite Stakeholders through to implementing the full business transformation.

Russell Harris

Russell is a Business Development and Procurement leader with a wealth of experience in developing contract manufacturing pipelines and sourcing multiple direct and indirect categories. He has gained extensive experience in pharmaceutical B2B sales. He has also been instrumental in delivering robust sourcing strategies on a global level. He has developed and implemented commercial strategies as well as launched and delivered multiple outsourcing strategic programs to support the profitability of multiple organizations including GSK, Abbott and a stand alone CDMO, Avara Pharmaceuticals.

Ken Chisholm

Ken has over 30 years of experience in Business Development, Strategy, B2B Sales, Global Planning and Technical. Ken's expertise lies in Business Development Transactions (Acquisitions, Divestments, Licensing and Due Diligence), Network Strategy & Sourcing (setting up and optimizing existing Supply Chains), Supply Chain Operations (Operational Excellence, Leadership and Coaching) and B2B sales (Strategy, Marketing, Contracting and Key Account Management). He has helped launch new products, rationalize global manufacturing operations, close and sell manufacturing facilities.