The Abingdon Team can advise and/or prepare INDs, including preclinical toxicology and safety pharmacology requirements, the overall clinical development plan, and CMC and stability issues

If your drug development plan is international in scope, or simply involves foreign sites for a US submission, Abingdon can provide expert analysis and execution of Clinical Trial Applications (CTA and CTX).

Abingdon is your choice for analysis of orphan drug opportunities in the USA and Europe. The team has considerable experience in preparing successful Orphan Product Applications and can provide expert advice and execution for both US and EU filings.

The Abingdon Team is expert in all aspects of US New Drug Applications, from pre-NDA strategic planning through Phase 1, 2, and 3 clinical trials to advisory committee presentation, final approval, and post market obligations.

For multinational drug development we can manage the preparation of EU submissions and other new drug registrations worldwide.

Issues surrounding the strategic planning of generic drugs and “follow-on” biologic product development are growing in complexity and depth.  Abingdon can provide expert consult and execution of generic drug submissions.

Abingdon will provide expert planning and management of your BLA submission through approval by FDA. 

The Abingdon Team will provide successful execution of medical device applications, either PMA or 510(k).  We advise on the design and appropriateness of clinical studies and their relationship to marketing claims and regulatory approval.

The Abingdon Team is very well experienced in all the various issues surrounding 505(b)(2) applications and can manage your application through FDA approval.

In those instances where a Fast Track application is appropriate Abingdon is your choice for expert execution.

Abingdon will provide expert advice and execution on drug promotion and advertising issues and FDA/DDMAC guidance.

The Abingdon Team will prepare and follow-up on requests for fact-to-face meetings with FDA, prepare pre-meeting information packages, and manage the preparation and conduct of the meeting.  Similarly, we can execute face-to-face meetings with other regulatory agencies in the EU, Canada, and other locations as required.

We can schedule, manage the preparation of pre-meeting information materials, and conduct face-to-face meetings with FDA and other regulatory agencies. The Abingdon Team can advise on and/or manage the strategic and tactical issues of various negotiation problems facing drug and medical device companies.

If you need expert assistance in a due diligence investigation, the Abingdon Team has a great deal of experience and is prepared to manage this process for you or advise on specific questions, whether they are CMC questions, preclinical toxicology issues, clinical study questions, or other questions.