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Registration

With extensive experience of drug registration procedures, we can help to bring drugs into clinical development and onto the market in the therapeutic areas of drug abuse and dependence, CNS disorders, obesity and type 2 diabetes.

  • Review of experimental and clinical data
  • Preparation of non-clinical sections of New Drug Applications (NDAs) for the FDA and Market Authorization Applications (MAAs) for EMA
  • Abuse liability evaluations of drug-candidates
  • FDA 8-Factor Analyses
  • EMA Abuse Liability Assessment Documents
  • Controlled drug scheduling assessments
  • Expert advisory support in negotiations with FDA, EMA and other regulatory agencies
  • Advocate support at Psychopharmacologic Drugs Advisory Committee (PDAC) Meetings and FDA and EMA hearings

Our expertise

We have provided key pre-clinical support for 12 drug registrations, including lofexidine (opiate withdrawal), cannabidiol (epilepsy), lacosamide (epilepsy), lisdexamfetamine (ADHD), guanfacine XR (ADHD), methylphenidate transdermal patch (ADHD), lisdexamfetamine (binge-eating disorder), Istradefylline (Parkinson’s disease), safinamide (Parkinson’s disease), zotepine (psychosis) and sibutramine (obesity).

Key publications

Heal DJ, Henningfield J, Frenguelli BG, Nutt DJ, Smith SL. Psychedelics - Re-opening the doors of perception. Neuropharmacol. 2018, 142:1-6.

Calderon S, Giarola A and Heal D. Regulatory framework and guidance to the evaluation of the abuse liability of drugs in the United States and Europe. In: Nonclinical Assessment of Abuse Potential for New Pharmaceuticals. Carrie Markgraf, Thomas Hudzik, David Compton (Editors). 2015 pp. 245-268.

Bolea-Alamañac B, Nutt DJ, Adamou M, Asherson P, Bazire S, Coghill D, Heal D, Müller U, Nash J, Santosh P, Sayal K, Sonuga-Barke E, Young SJ; British Association for Psychopharmacology. Evidence-based guidelines for the pharmacological management of attention deficit hyperactivity disorder: update on recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2014, 28:179-203.

Heal DJ, Gosden J, Smith SL. Regulatory challenges for new drugs to treat obesity and comorbid metabolic disorders. Br J Clin Pharmacol. 2009, 68:861-874.

OTHER SERVICES:
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