Ian McGuinness's Contact Details

Ian McGuinness's Company Details

PharmaAS

Duivendrecht, North Holland, Netherlands • 3 Employees
Pharmaceuticals

Pharma Advice & Solutions is an independent consulting company which offers, along with its key partners, a fully comprehensive platform to support the medical and pharmaceutical community.The aim of PharmaAS is to provide first class regulatory, medical and clinical services to help clients achieve their goals. Founded in 2017, PharmaAS uses the expertise of consultants who have also been involved in small, medium and large pharmaceutical companies, and the medical sector, at all levels, to ensure all clients' needs are met.How We Work:PharmaAS and our network of expert partners are fully equipped to be your long-term partner or simply your case-by-case experts. Using our extensive knowledge PharmaAS brings together the brightest teams to ensure your pharmaceutical needs are met.The PharmaAS network offers first class services within the medical and pharmaceutical sector to help small, medium and large companies to advance their plans and realise their regulatory obligations and ambitions.Some of the services offered include:Regulatory Strategy:• Regulatory strategy for all health products and regulatory requirements adapted to each country• Due Diligence of dossiers• Preparation of Scientific Advice meetingsRegulatory Registration:• Creation and review of dossiers• Readability User Testing• EU translationsRegulatory Maintenance• Marketing Authorisation Applications, registration follow-up, responses to queries• Variations, renewals, transfers• Review of artwork(non) Clinical:• Model Based Drug Development: strategic modeling & simulation based support to the pharmaceutical industry for decision making or regulatory applications• Regulatory support for clinical trials• Creation of expert statements e.g. ERA's, clinical and non-clinical Overviews• Risk Management Plans• Key Opinion Leader recommendation