Navigating a safe course through the stormy seas of Regulatory Affairs in the European Union needs skill, knowledge and perseverance. Filing a marketing application isn’t just a question of performing studies in accordance with ICH guidelines and submitting a few CTD modules. Some regulatory requirements are specific to the EU region and also particular national regulations. Factors such as location of the manufacturer, labelling requirements and leaflet testing, paediatric development plans and pharmacovigilance plans all need to be considered. There are concepts such as European Reference Product, Qualified Persons for QA and PV and responsibility for scientific affairs that need to be evaluated. Which of the three regulatory pathways should be selected and why? For a generic product how which reference product do you select? The questions are almost limitless and regulatory strategy and tactics have to be planned well in advance.
Acta Pharma Services was set up in 2001 to provide a professional, efficient and flexible range of consultancy services in regulatory affairs to the pharmaceutical industry. Based in London, England the company specialises in the preparation, filing and maintenance of marketing applications for the UK and European Union. Using Acta will allow you to achieve your aims and meet deadlines whilst controlling your costs.
