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 substance abuse, CNS disorders, obesity and type 2 diabetes.

Our services include:

• Review and interpretation 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 16 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).

OTHER SERVICES:

• Research & Candidate Selection
• Drug Development
• Marketing