Provision of the right regulatory advice, and approach to gaining regulatory approval is of fundamental importance in having a fluid and successful drug development process.

Regulatory Consultancy

• Regulatory Development Plan

• Regulatory input into development programme

• Product feasibility research and analysis

• Guidance for responses to warning letters, inspections and clinical events,

• Preparation/Coordination Paediatric Investigation Plans

• Preparation/Coordination of Scientific Advice Procedures

• Preparation for Competent Authority Meetings (e.g. Scientific Advice Meetings, Pre-Submission Meetings, Oral Explanations)

Marketing Authorization Application (MAA)

• Management of MAA procedures

• Planning, compilation and submission of MAA dossiers (initial submission, response to deficiency letters)

• Coordination of linguistic review of product information

• Maintenance of marketing authorisations, such as variations, renewals, line extensions, Periodic Safety Update Reports (PSURs) (in cooperation with our Pharmacovigilance and Medical Writing Departments)

Clinical Trial Applications

• Advice on clinical trial application requirements

• Preparation and management of clinical trial applications to Competent Authorities

• Investigational Medicinal Product Dossiers (IMPDs)

Quality Documentation using in-house or client templates and style guides

• Quality Overall Summary (Module 2.3)

• Quality Documentation (Module 3)

• Drug Master Files (DMF)

Electronic Submissions

• Electronic Common Technical Document (e-CTD) / Management of e-CTD lifecycle

• Non-eCTD Electronic Submissions (NEES) e.g. Clinical Study Report, Drug Master File