Meetings with regulatory agencies are a key part of the development and approval of new medicines and devices.
Product development meetings with FDA, EMA or various national regulators range from Pre-IND through various stages of scientific advice and marketing authorisations procedures.
We also support other meetings including development of drug development tools or biomarker qualification and strategic/portfolio interactions.
Our experience allows us develop strategies, lead meetings or coach teams in preparation for all types of regulatory interactions.
Investors and boards often need independent review of business or regulatory strategy.
We have provided strategic input to investors considering new opportunities and continued advice to these companies and their boards.
Our experience undertaking due diligence reviews of potential investment opportunities at all stages of development and advising potential investors provides independent expert views.
We are often asked by investors to continue to provide strategic advise to the management team or board.
Developing new therapeutics is a complex, collaborative process. It carries significant financial and operational risks.
Our experience across many therapeutic areas and stages of development enables us to provide advice on initial preclincial development plans leading to early clinical studies through to market launch activities.
Our extensive network provides access to a range of expertise in all aspects of medicine and device development.
Development of innovative medicines and therapeutics requires strong collaboration with regulators and other stakeholders, including patients and representatives of health systems.
Early input from patients and regulators will increase the liklihood of delivering successful innovations. Our experience in working with regulators, patients and academic stakeholders will enable optimal regulatory approaches.
Infectious disease remains a major global health challenge, exacerbated by challenges of antibiotic resistance and the lack of commercial incentives to develop new therapeutics.
We provide regulatory support to various modalities of therapeutic innovation including biologics, medicines and devices.
With decades of experience developing antiinfectives, Bob devotes a significant portion of his time supporting non-profit organisations developing new treatments in neglected infectious and other global health challenges.
Although we support a wide range of therapeutic areas, our experience in oncology gives us insights into personalised medicines, diagnostics and novel development programmes.
We can provide advice on adaptive and other trial designs, accelerated development pathways and diagnostic development.
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