Providing solutions to the challenges faced during transformational moments in your company.
Our Services
We apply our expertise in regulatory, translational, and clinical science built on our proven success in pharmaceutical drug discovery & development.
We support you from start to finish with our knowledge, integrity, and objectivity. Our services complement your own expertise & vision.
Receive a detailed copy of our Description of Services
Our Team
Prof. Benjamin J. Whalley
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VP leader, drug discovery, target validation, IND-enabling preclinical work, IND, NDA approval, and post-approval requirements FDA negotiations, NDA Advisory Committee success, patient group advocate Inventor first FDA-approved cannabis-based medicine 20+ years’ experience discovery to lifecycle management.
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Epilepsy and related symptoms and diseases; cannabinoid science and therapeutics; electrophysiology, ion channel and GPCR signaling; stem cell models of disease; animal models of disease; science and policy for drugs of misuse; botanically-derived medicines and nutraceuticals; primary and secondary care pharmacist
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Inventor >30 patents; neurological diseases; therapeutic use of cannabinoids.
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Pharmacologist, Professor of Neuropharmacology, (1991-2017); >6M GBP academic grant income; created School of Pharmacy, University of Reading, UK; Director of Research, Schools of Pharmacy, Chemistry, and Food Sciences; 24 PhD students supervised to completion.
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Fellow of the British Pharmacological Society; British Pharmacological Society Sir James Black Award for Contributions to Drug Discovery; Royal Pharmaceutical of Great Britain Annual Science Award.
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h-index: 43; i10-index: 88 https://scholar.google.com/citations?user=JbReS5gAAAAJ&hl=en
Mr Dennis E. Ahern
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VP leader, Global Regulatory Affairs and Due Diligence. Over 30-year career managing complex regulatory processes, ensuring product compliance, and building strong relationships with regulatory agencies. Skilled at developing and implementing regulatory strategies to provide timely product approvals and market access while ensuring full compliance with local and international regulations.
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Have directly led the submission and approval process of product applications and have mentored professionals to successfully deliver over 100 full or supplemental applications to FDA, EMA, Health Canada, Japan, and Growth Market authorities.
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Have led or coached colleagues and employees in senior-level meetings with members of the FDA’s Office of the Commissioner and associated policy groups.
Point-lead for three FDA Advisory Committee Meetings and prepared professionals for a host of additional meetings by functioning in the role of challenge team member and mock panelist.
Have led the planning and execution for successful oral explanation and Scientific Advisory Group meetings at EMA.Led or have been part of various development and milestone meetings with FDA, EMA and European National Authorities (UK, Germany, Netherlands and Sweden) as well as Australia, Brazil, Canada, Israel, Japan, Russia, and Switzerland.
Inspections – have co-hosted as well as been a subject matter expert on product quality, manufacturing, and pharmacovigilance inspections (FDA, UK MHRA, Health Canada, and Japanese PMDA).
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Associate Adjunct Professor, School of Pharmacy, Temple University (2001 – 2009).
Developed curriculum in 2001 for a new graduate-level course in critical thinking and regulatory strategy entitled “Industry Interactions with FDA and Health Authorities.”
Taught course to graduate students until 2009.
