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59680279

Biotechnology Development Consultants

what we do

Consultancy, Management Expertise & Training

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.

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01
CMC & Manufacturing

CMC & Manufacturing

Process Development, MSAT & Validation. Developing & optimising processes, including using QbD approaches, enabling well controlled & robust processes that can progress to PPQ and commercial launch.
CMC & Manufacturing
02
Assays & Quality Control

Assays & Quality Control

Analytical & Bioassay Development & Validation. Analytical methods used for product release & stability, including potency assays & product characterisation, are suitably optimised & validated in line with ICH guidance.
Assays & Quality Control
03
QA, Auditing & Regulatory Affairs

QA, Auditing & Regulatory Affairs

GxP mandates supplier audits, quality reviews, Quality Management Systems (QMS) & QP release. Regulatory strategy & filing support on biological products for dossier submissions.
QA, Auditing & Regulatory Affairs
04
Programme & <br/>CDMO Management

Programme &
CDMO Management

Effective project management of programs from research to launch, combined with efficient management of CDMOs, streamlining the development path to market.
Programme & <br/>CDMO Management
05
Strategic Planning & Due Diligence

Strategic Planning & Due Diligence

Supporting due diligence for evaluation of potential business investment decisions and strategic planning of development activities for successful business outcomes.
Strategic Planning & Due Diligence
06
Formulation Development <br/>& Stability

Formulation Development
& Stability

Developing formulations alongside accelerated stability & forced degradation studies ensuring the most suitable excipients for maximising product potency & shelf life.
Formulation Development <br/>& Stability
07
Preclinical, <br/>Non-clinical & Toxicology

Preclinical,
Non-clinical & Toxicology

Preclinical & toxicology support for programs progressing to clinical stage studies and requiring mechanism of action and safety support for regulatory submissions.
Preclinical, <br/>Non-clinical & Toxicology
08
Clinical Development <br/>& Monitoring

Clinical Development
& Monitoring

Supporting the management & monitoring of clinical research organisations (CRO) in the execution of client clinical programs including clinical project management.
Clinical Development <br/>& Monitoring
GRA: The Biotech Consultancy
who we are

GRA: The Biotech Consultancy

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.

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Biotech Experts in Clinical Product Development

Your partner in improving lives

Contact Us
Technologies

Services We Provide

  • Biotechnologies
  • Vaccines
  • Cell-based Therapies
  • Gene Therapies
Biotechnologies

Biotechnologies

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.

the development process

How We Help

1
Poison sample
Preclinical

Translating science into development-ready strategies

Developing proof of concept to support filings

Considering regulatory and CMC up-front

2
Person and a dropper
Phase I

Establishing regulatory strategies, quality systems & CMC processes

Managing CDMOs for clinical manufacturing & analytics

Ensuring smooth clinical supply for FIH trials

3
Formulation development
Phase II

Optimising processes & assays using QbD

Working with global agencies on regulatory strategies

Ensuring clinical materials are comparable between trials

4
Three people and approved dropper
Phase III

Ensuring CMC & quality systems are ready for production

Planning & executing PPQs & assay validation

Supporting late-stage trials & inventory management

5
People around the globe
Commercial

Developing supply chain strategies with regulatory compliance

Supporting product launch & lifecycle management

Navigating global regulatory approvals

the team

Our Associates

Lee Smith
Lee Smith
Managing Partner & Director

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.

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Samantha Dowse
Samantha Dowse
Managing Partner & Director

Sam is a deeply experienced CMC analytical program leader who enjoys building client relationships and taking an adaptive, pragmatic approach to deliver tailored solutions to complex problems.

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Andrew M Thomson
Andrew M Thomson
Managing Partner & Director

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.

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Rod O’Keeffe
Rod O’Keeffe
Senior CMC Consultant

Extensive experience in the development of biological products across diverse disciplines, including regulatory experience in authoring CMC sections for clinical trials and commercial registrations.

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Cora Henwood
Cora Henwood
Senior CMC Consultant

Cora has over 30 years’ experience in biologics development with specific expertise in downstream process (DSP) development of processes.

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Leonardo Sibilio
Leonardo Sibilio
Senior Process Consultant

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.

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Andrew Thomson
Andrew Thomson
Senior Analytical Consultant

Andrew brings Analytical development, QC consultancy an Analytical support, specialising in biophysical methodology and supports biopharmaceutical clients.

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John Little
John Little
Senior Analytical Consultant

A Scientific Leader with extensive experience of developing biopharmaceutical and gene therapy products, in the academic, public, and private sectors and through freelance consultancy.

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Melody Janssen
Melody Janssen
Senior Pre-Clinical Consultant

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

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Ronan O’Kennedy
Ronan O’Kennedy
Senior Process Consultant

Expert commercial process scientist including biopharmaceutical development and technical transfer, mammalian and microbial cell upstream process development, data analysis and QbD.

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Joseph Irwin
Joseph Irwin
Senior Consultant – Regulatory Affairs

Highly experienced Regulatory Professional adept at leading International Regulatory Agency submissions and interactions.

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Jean-Marc Wilkin
Jean-Marc Wilkin
Senior Consultant - CMC Regulatory

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.

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Jacqueline Abbas
Jacqueline Abbas
Senior Consultant - Programme Management

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.

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Jim Mills
Jim Mills
Associate Consultant

A bioprocess and biopharmaceutical executive with 30 years of experience. Expertise includes manufacturing technical due diligence, technology assessment, and company acquisition technical due diligence.

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Alan Savage
Alan Savage
Associate Consultant

Alan is an experienced quality professional with over 40 years of experience in the pharmaceutical industry. He specialises in R&D and production facilities

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Gary Wilcock
Gary Wilcock
QA professional

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

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Irwin Hirsh
Irwin Hirsh
Senior Process Consultant

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.

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Warren Roche
Warren Roche
Associate Consultant

Consultant Statistician, providing expertise aligned with the latest regulatory guidance. Focus includes shelf-life determination, method and process development, validation and specification setting.

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SOTA Kurita
SOTA Kurita
Consultant

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.

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Mike Breese
Mike Breese
Senior Quality Consultant (QP)

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.

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Lori Rinckel
Lori Rinckel
Senior Analytical Consultant

Detail-oriented scientist with 25+ years’ experience with cGMP and GLP regulated products. Expert in development, optimization, qualification, validation, transfer, implementation, testing, and review.

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Dina Anderson
Dina Anderson
Senior Consultant - Programme Management

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.

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Spiros Servos
Spiros Servos
Commercial Strategy Consultant

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.

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Tiffany Rau
Tiffany Rau
Senior CMC Consultant

Nearly 20 years CMC Manufacturing and Strategy experience in mammalian and microbial systems, plus QbD and six sigma black belt.

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insights

Latest Articles

01

COVID-19 Case Analysis 23 Jan to 29 March 2020

Animated bubble plot of cumulative COVID-19 cases & deaths by country.
 read more
02

Live Attenuated Viral Vaccines Advancements

Innovation is continually taking place for a generation of new vaccines to meet patient needs across the globe.
 read more
03

Hope for Chlamydia STI Vaccine After Promising Initial Results

A vaccine to protect against Chlamydia has taken a step closer to licensure after successful phase 1 clinical trials.
 read more
04

Gene Therapy for Rare Disorders

Of the many medical breakthroughs over the past three decades, few have been as promising as gene therapy.
 read more
05

CEPI awards up to US$21 million to Themis Bioscience for Phase 3 Chikungunya Vaccine Development

CEPI awards US$21 million to Themis Bioscience.
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