Overview
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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