
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.
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.
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
Extensive experience in the development of biological products across diverse disciplines, including regulatory experience in authoring CMC sections for clinical trials and commercial registrations.
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.
Andrew brings Analytical development, QC consultancy an Analytical support, specialising in biophysical methodology and supports biopharmaceutical clients.
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.
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.
Consultant Statistician, providing expertise aligned with the latest regulatory guidance. Focus includes shelf-life determination, method and process development, validation and specification setting.
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.
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.
Detail-oriented scientist with 25+ years’ experience with cGMP and GLP regulated products. Expert in development, optimization, qualification, validation, transfer, implementation, testing, and review.
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.