Assessing a new inhalation device and assisting with partnering

Challenge: A medical device company has developed a nebulizer system for pulmonary delivery that can produce droplets below 1.5µm diameter. Initial clinical evaluations of demonstrator compounds used...
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Clinical and regulatory support for respiratory delivery specialist

Challenge: A respiratory delivery specialist company was looking at established drugs to assess the attractiveness and risks of developing inhaled or intranasal formulations of selected molecules. It...
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Valuation of a radiolabeled peptide for diagnosis of pulmonary diseases

Challenge: In preparation for fundraising, a biotech company developing a clinical stage radiolabeled peptide to diagnose pulmonary diseases required an independent valuation of its technology in...
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European market access support for clinical stage biopharma company

Challenge: A clinical stage biopharma company developing a novel small molecule to treat a rare respiratory disorder had conducted an Advisory Board to finalize the design of later stage clinical...
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Providing in-licensing due diligence on a Phase IIb respiratory drug

Challenge: A pharma company needed help conducting due diligence on an in-licensing/acquisition candidate for a Phase IIb respiratory drug.
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Providing due diligence on a cell biology reagents investment

Challenge A major UK bioscience investor needed due diligence on a cell biology reagents investment opportunity.
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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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Supporting due diligence on regulatory affairs in the respiratory field

Challenge: A clinical stage biotech needed support with its regulatory due diligence activities for products in the respiratory field.
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