PRODUCT DEVELOPMENT SERVICES
Regulatory Affairs

ICON Development Solutions is a leading provider of outsourced regulatory support to the pharmaceutical, biopharmaceutical and medical device industries. With offices in the UK and US, and additional staff based elsewhere in the EU, we can deliver global, regional or local scale projects.

Apply our expertise in product development strategy and planning, we offer:

	Advice on:
Global regulatory requirements    Regulatory strategy
	Interaction with regulatory agencies
Including EMEA, EU national agencies, FDA and other international agencies    Representation of clients or participation at regulatory agency meetings
	Preparation of submission components and scientific documents including clinical, non-clinical and quality summaries and overviews.
	Publishing, both paper and electronic
	Submissions management
	Review and evaluation of regulatory data e.g. due diligence
	PIL user testing

Whether as part of an overall programme management or provided on a standalone basis, we can help with the full range of regulatory projects including clinical trail applications (CTA), investigational new drug applications (IND), drug master files (DMF), pre-meeting briefing packages, marketing applications (e.g. CTD, MAA, BLA, NDA), orphan product designations, responses to agency questions and appeals, life cycle management and maintenance (e.g. annual reports, periodic safety updates, variations, renewals).

We have one of the largest, longest established and most experienced contract regulatory groups with extensive experience from previous senior roles within a variety of multinational pharmaceutical companies. All of our consultants have a minimum of 5 years experience, and many have considerably more. This experience, our proven track record of success and ISO quality certification makes ICON Development Solutions a preferred partner for many of our clients, as proven by our 85% repeat business.