Pharma consulting in manufacturing transfer and scale-up for Phase III trials

Challenge A small biotech company had undertaken several projects in clinical development and needed focused CMC consultancy support in progressing to the next phases of these ventures.
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Gap analysis of a US CMC data package for a European submission

Challenge A small regulatory company had been commissioned to review the development data package available from a US biotech company for a liquid inhalation product, with a view to using the data...
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CMC consulting for a company developing a peptide

Challenge A small biotech company was developing a peptide and needed support in taking the compound to first-in-man studies and Phase II clinical trials. This was the first time the company had...
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CMC & manufacturing support for biotech developing a novel small molecule

Challenge A biotech company was developing its first oral compound — a novel small molecule. The company needed support in taking the compound to first-in-man studies and Phase II clinical trials.
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Economic impact of research institute

Challenge A UK public sector life sciences research institute focused on fundamental mammalian biology required an economic impact assessment of its science, as part of the evidence base accompanying...
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Acting as an expert observer on the board

Challenge A private equity (PE) investor was looking for a partner to be retained as an observer on the board of a regenerative medicine/advanced wound-healing company.
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Independent review of oncology clinical trial data

Challenge A biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s management and...
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Consulting on monoclonal antibodies to treat bacterial infections

Challenge An established US biotech company was looking for a team of expert antibody consultants to help them understand the potential of monoclonal antibodies (mAbs) to treat bacterial infections.
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BLA submission support for a novel antibody-based therapeutic

Challenge Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum...
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Regulatory due diligence

Challenge A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.
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Supporting medical device 510(k) submissions

Challenge A company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA.
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Submitting 510(k) applications

Challenge A medical device client needed help securing 510(k) clearance for a non-contact respiratory measurement device.
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