Kathleen Seward's Contact Details

Kathleen Seward's Company Details

SKS Consulting Ltd

Newcastle upon Tyne, England, United Kingdom • 16 Employees
Pharmaceuticals

SKS provides specialist advice and consulting services in Regulatory Affairs and Project Management, acting as a liaison between Departments of Health/ Regulatory Agencies and healthcare product manufacturers and licence holders.Founded in 2004, SKS is a small consultancy that provides the Healthcare Industry with a reliable, responsive and high quality service, with our knowledge and experience of both the profession and the industry being the backbone of our services, and true professionalism and attention to detail some of our core values.Regulatory recruitment solutions are also provided, for all levels, and tailored to fit either client or candidate. The approach is consultative and non-intrusive, which has provided for a successful track record in this area. SKS can undertake or resource your regulatory affairs projects irrespective of size or schedule, and across healthcare sectors including consumer healthcare, pharmaceuticals, generics, herbal, nutraceutical and API manufacturing.√ API manufacture - API registration through the ASMF or CEP procedures, or compilation of the Drug Substance dossier√ OTC – consumer product information and readability testing, reclassifications and full-range maintenance activities√ Herbal - expert advice and guidance in the preparation and registration process for THMPs or MAs (WEU)√ Nutraceutical – product registrations or notifications. Evaluation of product compliance and safety, dossier and consumer materials preparation√ Pharmaceutical – Lifecycle management strategies, patent extensions, line extensions, acquisitions, due diligence, generic opportunities, also licence maintenance and outsourcing activities√ CMC – expert review or compilation of CTD Module 2 and 3 dossier for medicinal product registrations