GreyRigge Associates is a global biotech partner delivering 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.

We specialise in early-stage product development through to late-stage development and, ultimately, product launch. Our consulting services cover:

- CMC & Manufacturing
- Assays  & Quality Control
- QA, Auditing & Regulatory Affairs
- Programme & CDMO Management
- Strategic Planning & Due Diligence
- Formulation Development & Stability
- Preclinical, Non-clinical & Toxicology
- Clinical Development & Monitoring

Recent projects: 
- CMC process & formulation development, including CDMO(s) management for peptides, therapeutic proteins, live vaccines and a novel recombinant protein 
- Analytical development & Stability management for monoclonal antibodies and antibody fragments, a bispecific antibody domain, therapeutic proteins, live vaccines, peptides, antibody drug conjugates (ADCs) and CGT from stem cells
- CMC, SDM and MSAT regulatory support for mAb biosimilars, providing external review of the process and analytical characterisation, validation and other CMC BLA supporting activities
- CDMO selection & Management and process development 
- Extractables & Leachables risk assessment activity 
- Cell-based bioassay development for an ADC 
- Cell banking for a vaccine platform 

We help: 
- Biopharmaceuticals looking for consultancy, programme management, extra team support or training
- Investors looking at novel assets requiring support to investigate opportunities, valuation and due diligence

We love working with collaborative and supportive fellow experts, so if you are an experienced consultant open to rewarding freelance opportunities, then contact us.

GreyRigge Associates: Experts | Transformative | Agile
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GreyRigge Associates

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GreyRigge Associates

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