
Biotechnology Development Consultants

Biotechnology Development Consultants
Biotech Experts, Transformative Impact, Agile Solutions.
GRA is grounded in the development of Biologics and Advanced Therapies (ATMPs). We cover a broad range of modalities including monoclonal antibodies, ADCs, biosimilars as well as cell-based & gene therapies and all vaccine forms.
We support start-ups to multinational organisations, whether at the bench or on the board, GRA delivers client focused consultancy and management expertise. We perform client training to ensure that you are up to date on the latest regulatory and technical requirements.
Technical Expertise: Our experts provide consulting capabilities to support clinical development through to launch. We have expertise in CMC (manufacturing & analytical), quality (QA), regulatory affairs (RA), pre/non-clinical development, clinical development & monitoring. All activities are supported with experienced project management that ensure timely completion of programme objectives within acceptable risks & agreed budgets to help eliminate costly mistakes and program delays.
Commercial Expertise: We serve on advisory & company boards, frequently conducting investor due diligence. We support clients on commercial aspects of programs. These including market analysis, licensing opportunities, pipeline evaluation, portfolio prioritisation, competition analysis, product pricing and NPV determinations. We can also assist with due diligence activities (inbound and outbound) and even support you with negotiation of agreements, whether commercial licencing or clinical or commercial supply agreements for external production.
Training: Our programmes are specifically tailored to your needs and can be delivered in person or online. We currently have programmes covering CMC including phase appropriate process and analytical development, quality management and regulatory requirements. We specialise in Quality by Design, Design of Experiments and their statistical application to CMC, including process and analytical, including cell based bioassays.
Experts | Transformative | Agile
GreyRigge Associates (GRA) is a global biotech partner that was founded in 2010. We deliver consultancy, management expertise and training across the entire product development journey. Our extensive biopharmaceutical industry experience and pragmatic, agile approach enables transformational success by accelerating our clients’ medicines to market. GRA has offices in the UK, the USA and Asia-Pacific, providing support worldwide.
Experts | Transformative | Agile. Do this right and the results follow. We want trusted long-term replationships with our clients
The breadth of our service portfolio, the depth of our experience, our global capability, the testimonials and repeat contracts that we manage. Greyrigge Associates are proven and we are resilient. Our business shows consistent year-on-year growth and is committed to bringing in the most experienced and proven Associates to strengthen our bench. This all means that we focus on the results that you need. By making it easy to work with us, we can focus on the project and not just the resourcing. Add to this our skills in helping to commercialise your project and our links to multiple global research, university and govermental programmes, we bring so much more than alternative consultant suppliers.
But don't just believe us, read our testimonials and if you need to talk with one of our clients, let us know and we can facilitate that. This is one of the most crucial decisions that you are going to be making regardless of your organisational size or stage in the process.
Delivering biotech consultants is not the only thing that we do. We are often invited to sit on Boards and Panels, to act as advisors and help commercialise the oppotunities of our clients. Whether it is valuation, due-diligence or establishing exit paths for founders, or acquisition, merger and divestment or licencing through partnerships, we have the experience to help you make better, data-driven decisions.
We also work with VC's and are often asked to safeguard their investments, bringing our market and business understanding to improve the commercial outcomes of all parties. We add credibility to projects securing stronger client outcomes and can bring in financing solutions as needed.
Like the biotech industry, GreyRigge Associates is a truly global consulancy and focuses resources where you need them. If we are not in your precise location, rest assured that our follow-the-sun capability and dextrous use of online collaboration tools means that we are a part of your team quickly and efficiently.
Given the high risks and high costs of biopharmaceutical development, you need the most appropriate expertise that you can find. We offer that expertise. Furthermore, GRA has global networks that can provide links into academic or industrial capabilities that you’ll likely need. GRA communicates with clients through a combination of face to face, telephone and online web tools such as Teams, Zoom, Skype & Webex as well as email. We typically use your inhouse collaboration tools to share work and deliver our projects.
GRA successfully works with clients across multiple timezones working with companies across the Americas, on to Europe through to Asia and Australia and repeat, with proven projects including companies such as Takeda, Ipsen Biopharma, Mesoblast, Themis Bioscience, FluGen & Abcam.
Fixed price and time-and-materials cost are the two primary methods for consultancies to price their services.
These each present varying advantages and disadvantages to the client and to the consultant. For where a clear scope of work is provided, a fixed price can be ideal as the client will know what they will be paying and can budget accordingly without worrying that costs will get out of control. However, if the scope of work changes or wasn’t clear from the beginning, then a time-and-materials basis may be more appropriate. With this approach, the client will pay a daily or hourly rate and GRA will send a list of hours worked together with the total fee due. This approach is more flexible with the client 100% sure that they’ll gets the solution fully corresponding their expectations. However, costs must be monitored carefully as they can accumulate over time.
GreyRigge Associates is flexible in its approach to billing. This can be discussed at the beginning of the project to agree what is most appropriate for the client needs.
This is critical. You need the right skills and the right aptitude to fit in with your team and deliver both independently and with the right level of interdependency. We know this and so spend the time matching you with the right associate from GreyRigge. Our senior leadership team, including Dr. Lee Smith and Samantha Dowse will work with you to establish a clear scope of works and understand the exact skill-set that you need. They would then match with our range of Associates and go through an on-boarding exercise to ensure that the resourcing works for us all. Depending on the size of the project, multiple Associates may be involved.
Building and maintaining your trust in our serivces, company and Associates is of paramount importance to us, especially as your success frequently results in further assignments which reinforce our position as your trusted resource partner.
Most of Greyrigge Associates consultants have a deep domain experience exceeding 20 years from working in industry. Click through to the 'Associates' tab in the top navivation bar to see our extensive range of associates and their expertise. We have around 1000 man-years of biotech expertise at our disposal. Our founder, Dr. Lee Smith has a Ph.D. and over 25 years experience working in the Biotech industry. All GRA associates hold a minimum of a Bachelors degree and mostly Ph.D.s, plus many years experience in the industry. We will always discuss with you who would work on your project. We have proven track records or success as shown in our testimonials on the Home page. Brief biographies of GRA associates can be found here.
Every client situation is unique. Sometimes, we are the team and sometimes we stand shoulder to shoulder with your inhouse team But to outline a typical approach, then it would include the following steps:
We have extensive experience working on the development of biopharmaceuticals & ATMPs. We also work on test designs for device development including PoC as well as supporting laboratory instrument optimisation.
Lee founded GRA and has a passion for developing medicines and improving lives by helping biotech companies succeed through guiding a product’s development to licensure.
Sam is a Director and Managing Partner with a passion for improving lives and brings extensive experience in CMC program development with specific expertise in Analytical and Shelf Life assignment.
Andrew directs the APAC subsidiary, bringing deep experience in Medical Research and Life Sciences in microbiology, molecular and cellular biology, assay development, process development and CDMO management.
Extensive experience in the development of biological products across diverse disciplines, including regulatory experience in authoring CMC sections for clinical trials and commercial registrations.
Andrew brings Analytical development, QC consultancy an Analytical support, specialising in biophysical methodology and supports biopharmaceutical clients.
Cora has over 30 years’ experience in biologics development with specific expertise in downstream process (DSP) development of processes.
Deep experience in Process Development of mAbs, recombinant proteins, and adenoviral vectors. Expert in GMP Manufacturing up to 2,000 L bioreactor scale. Regulatory support (CMC) for IMPD and BLA.
A Scientific Leader with extensive experience of developing biopharmaceutical and gene therapy products, in the academic, public, and private sectors and through freelance consultancy.
Expert in immunology, immunogenicity and (bio)analytical sciences, across small molecules, biologics, vaccines, drug delivery systems, gene & cellular therapies - GMP, GLP, and GCP, non-clinical, and translational development
Expert commercial process scientist including biopharmaceutical development and technical transfer, mammalian and microbial cell upstream process development, data analysis and QbD.
Highly experienced Regulatory Professional adept at leading International Regulatory Agency submissions and interactions.
Accomplished senior regulatory professional with over 25 years of experience in research and development of biotechnical products in the pharmaceutical industry, supported by 10 years hands on research work.
Over 25 years experience in early stage biotech, biopharma and CROs across global programme leadership, clinical development & operations, medical and regulatory affairs from pre-clinical through life-cycle management.
A bioprocess and biopharmaceutical executive with 30 years of experience. Expertise includes manufacturing technical due diligence, technology assessment, and company acquisition technical due diligence.
Detail-oriented scientist with 25+ years’ experience with cGMP and GLP regulated products. Expert in development, optimization, qualification, validation, transfer, implementation, testing, and review.
Consultant Statistician, providing expertise aligned with the latest regulatory guidance. Focus includes shelf-life determination, method and process development, validation and specification setting.
Mike is an established QA professional with Qualified Person status and extensive experience in the Life Sciences Industry. An interim QP/Auditor for Fisher who has consulted for more than 20 years.
Alan is an experienced quality professional with over 40 years of experience in the pharmaceutical industry. He specialises in R&D and production facilities
BA strategic leader and expert in all aspects of Pharmaceutical CMC and QA, with over 35 years of relevant experience. Proficient in all dosage forms
30 year background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. QbD and DSP expert building process-oriented systems within CMC and quality departments.
Deep experience in academia, start-up/biotech, midsize and large Pharma. Excellent communication and track record of project management, scientific leadership, R&D lifecycle delivery and post-marketing initiatives.
RNA therapeutics expert and dealmaker with over 20 years in biotech. A PhD in molecular biology, with a focus on oral vaccines, and an MBA demonstrating his deep understanding of both scientific principles and business strategy.
Nearly 20 years CMC Manufacturing and Strategy experience in mammalian and microbial systems, plus QbD and six sigma black belt.
Sota-san has >30 years Pharma/Biologics experience as an established CMC professional and consultant. He bridges Language and Regulatory gaps between Japan and rest of the world.
Translating science into development-ready strategies
Developing proof of concept to support filings
Considering regulatory and CMC up-front
Establishing regulatory strategies, quality systems & CMC processes
Managing CDMOs for clinical manufacturing & analytics
Ensuring smooth clinical supply for FIH trials
Optimising processes & assays using QbD
Working with global agencies on regulatory strategies
Ensuring clinical materials are comparable between trials
Ensuring CMC & quality systems are ready for production
Planning & executing PPQs & assay validation
Supporting late-stage trials & inventory management
Developing supply chain strategies with regulatory compliance
Supporting product launch & lifecycle management
Navigating global regulatory approvals