Applying broad clinical, industry and regulatory experience to bring independent advice on drug development and licensing
Identifying drug development challenges early & providing solutions
Preventing common pitfalls in drug development
Appraising products and clinical development data for in and out-licensing
Advising, writing and approving clinical development plans, clinical appraisals, investigator brochures
Acting as Sponsor representative for electronic EMA regulatory applications e.g. PIP, Orphan Drug Designation
Designing and setting up phase I-III trials, assessing results, producing clinical study and clinical programme reports, summaries and overviews
Strategic advising via membership of clinical or regulatory advisory boards
Supporting data safety monitoring boards
Providing medical support or management unavailable in-house
Advising on regulatory strategy, requirements and guidelines to ensure regulatory acceptance of data and avoiding unnecessary costs
Advising on, or developing, internal regulatory strategy
Pre-empting regulatory problems through regulatory audit of drug development programmes
Providing pre-submission medical and regulatory assessment
Avoiding common omissions and deficiencies in marketing authorisation applications (MAA)
Writing SPCs, PILs, clinical overviews (module 2), clinical dossiers (module 5) for all types of medicinal product licensing
Supporting pharmacovigilance requirements during development and post-licensing e.g. adverse event assessment, PSURs, safety overviews, risk management plans and annual safety assessments
Using detailed knowledge of how UK and EU licensing works, predicting what regulators will say, pre-empting licensing delay or failure
Supporting clients throughout UK and EU regulatory procedures; liaising with regulatory authorities on behalf of the client
Finding timely solutions to regulatory issues; providing credible review of a regulatory turndown
Supporting UK and EU scientific advice, oral explanations, hearings, mutual recognition (MR) and decentralized breakout sessions, requests for further information for centralized, orphan drugs, MR and decentralized procedures