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Unicus Regulatory Services Limited

Unicus Regulatory Services Limited. Core Business Areas. Key facts. Established in 1996 HQ located in Berkshire (Wokingham) A private limited company + 50 full-time staff & a growing number of freelance specialists Service provided in-house and on client sites

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Unicus Regulatory Services Limited

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  1. Unicus Regulatory Services Limited

  2. Core Business Areas

  3. Key facts • Established in 1996 • HQ located in Berkshire (Wokingham) • A private limited company • + 50 full-time staff & a growing number of freelance specialists • Service provided in-house and on client sites • Capability in all aspects of regulatory and pharmacovigilance support

  4. Clients • 140 clients in UK, EU, USA and international territories • Unicus has worked successfully with 8 out of the top 10 pharmaceutical companies, and 5 out of the top 10 biotech companies • Clients include small, medium and ‘blue chip’ pharma companies, as well as generic and herbal medicine producers

  5. Past and Current Clients Medium Regulatory Pharmaceutical Authorities / Trade Associations Small Pharmaceutical Biotechnology / Multinational Start-ups / Pharmaceutical Universities

  6. Management team

  7. Regulatory Affairs • Exceptional regulatory professionals with many years experience • Highly skilled, dedicated, flexible teams available to suit your requirements • Proven track record in providing innovative and cost effective support for over 10 years • Ability to deliver bespoke regulatory solutions to meet all clients requirements

  8. Regulatory Affairs • Mutual Recognition Procedure • Centralised Procedure • EU National Procedures • Liaison with EEA Agencies • Scientific Advice • Generic and New Drug Applications • Clinical Trial Applications • Due Diligence • Regulatory intelligence • Training (e.g. submission writing) • CMC, Pre-clinical and Clinical expertise • Experience in UK/Ireland, EU and International Markets

  9. Regulatory Affairs • Cardiovascular • Oncology • Analgesics • Dermatological • Anti-infective • CNS • Biotechnology • Gastrointestinal • Respiratory

  10. ePublishing • A truly comprehensive document management and electronic submissions service lead by a recognised expert with 28 years experience • From eCTD readiness assessments, and validation and installation of EZsubs on client sites to CTD conversions • Allow your organisation to reap the benefits of effective document management systems

  11. User Testing • Consultation with target patient groups to demonstrate the readability of the package leaflet is: • An integral part of New Marketing Authorisation Applications • A service provided by Unicus since March 2000

  12. User Testing • Specific solutions to meet client needs from one product to complete portfolio • Portfolio analysis to confirm approach- PIL design- full test, focus, bridging • Project managed service provided by a highly skilled and dedicated team to support successful authorisation

  13. Pharmacovigilance • New directives and regulations have enhanced the way in which patient safety monitoring is conducted, and this can place a significant burden both in terms of resources, expertise and time needed to ensure compliance • An accurate and comprehensive pharmacovigilance system that monitors risk:benefit profiles of products both pre and post-marketing is essential to the protection of patients and public health

  14. Pharmacovigilance • A team of PV experts, with over 120 years of collective experience • Using the Arisg database we provide a full PV service to a broad range of clients that includes:

  15. Pharmacovigilance • Clinical Trials safety reporting • Monthly line listings and annual safety reports • Post marketing safety reporting • Electronic expedited reporting, PSURs • Global weekly literature searches • Risk Management Plans • Medical safety reviews • Training of PV and non-PV staff • Preparation for PV audits

  16. Training • ‘What if I train my people and they all leave?’ What if you don’t and they all stay? • Numerous surveys have demonstrated that investment in training improves staff retention In the ever changing world of regulatory affairs, providing tailored focussed training to improve staff performance is critical to success

  17. Training • Bespoke solutions to meet your staff development needs • Current Offerings include: • An introduction to regulatory affairs • Management of European Procedures • Authoring and review of high quality submission documents • Interactive and facilitated sessions on the drug development process using the unique game: ‘MeduMaze’

  18. Coaching & Development The success of a business may be enhanced by enabling every individual within that business to perform at their best In a highly competitive industry, being able to unlock the potential of individuals and teams is the key to ensuring companies meet their objectives and stay ahead of the rest

  19. Coaching & Development • Programs include: • 1:2:1 Executive Coaching • 1:2:1 Career Coaching • Team building for new teams • Team building for existing teams • Improving virtual team performance • Organisation development • Leadership in uncertain times • Customised in-house programmes

  20. Coaching & Development ‘Unicus style and coaching expertise equip you for the managerial and personal challenges ahead, encouraging and supporting you to reach for the impossible’ Site Head of PD Regulatory Affairs, Roche UK

  21. Thank you Please see our website at www.unicus.co.uk

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