Let our experts guide your regulatory affairs strategy to help you get the most from your products in the best possible timeframe. After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment.
The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a medicinal product. Dossiers are at the forefront of this process. We can prepare the dossier, publish in the right format and manage the procedure from submission to close-out and our experts can assist you with the preparation of responses to questions raised by the regulatory agency. Once registration is complete, we can support you with ongoing maintenance for the registration dossier. We can also review existing dossiers for gaps and regulatory compliance
Scientific Advice Meetings with regulatory agencies can be very useful. Our team can guide you through the entire process, from making the meeting arrangements and preparing the list of questions with briefing information, through to chairing your meeting and formalising the outcome
Our regulatory specialists can assist with changes in legal status for your prescription medicine portfolio. Our experts will liaise with relevant regulatory authorities, healthcare professional and consumer-patient organisations to determine current opinion and assist in the development of the regulatory affairs strategy. We will also prepare the registration package and manage the regulatory process.