Drug Development

• 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

Licensing

• 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