Trusted by biotech & pharma organisations worldwide.
GreyRigge Associates (GRA) is a specialist biopharmaceutical consultancy delivering expert CMC, regulatory affairs, quality assurance, clinical development and strategic advisory services, helping biotech and pharmaceutical organisations of all sizes navigate the complexities of drug development with confidence.
Biopharmaceutical Consultants: Expert, Agile, Transformative
Founded in 2010 by Dr. Lee Smith, GRA has built a global network of over 25 highly experienced associates, each bringing deep, hands-on industry expertise across the full biopharmaceutical product lifecycle, from preclinical development through to commercialisation and post-approval support. Our associates bring combined years of real-world biopharma industry experience across biologics, monoclonal antibodies, ADCs, biosimilars, gene therapy, cell therapy and all vaccine forms.
Our consultancy, management and training services are designed to integrate directly into your programmes, working side-by-side with your teams with a practical, solutions-driven mindset. Whether you need to accelerate a CMC programme, prepare for an MHRA or FDA regulatory submission, implement a GMP quality system, optimise formulation development, manage a CDMO relationship, or evaluate a pipeline asset, GRA provides the specialist expertise your organisation needs, when you need it.
We are trusted by organisations ranging from early-stage biotech start-ups to global pharmaceutical companies. Our work spans the full breadth of biopharmaceutical development, from bench to board.
Our Global Reach
With offices in the UK, USA and Japan, GRA operates a follow-the-sun model that allows us to support clients across global time zones — 24 hours a day, 7 days a week. In 2024, Andrew M. Thomson joined founding partners Dr. Lee Smith and Samantha Dowse to lead the Asia Pacific subsidiary, completing GRA's international coverage and reinforcing our commitment to supporting global clients wherever they operate.
Why GreyRigge?
About Our Name
The name GreyRigge pays tribute to Dr. Lee Smith's family heritage, rooted in the Cumbria region of the Lake District, England, one of the UK's most iconic landscapes. The GRA logo draws inspiration from the region's mountains and lakes, reflecting the values at the heart of everything we do: sound foundations, natural fluidity, and the resilience to navigate challenging terrain.
These are not just brand values, they are the principles our associates apply to every programme we support.
Work With Us
Whether you are a biotech start-up preparing for your first regulatory submission or a multinational managing a complex global development programme, GRA has the expertise and the network to support you.