Services
Partnerships to success
Regulatory strategy
Early design of the regulatory strategy is one of the key elements for the successful marketing authorisation. We help our clients navigate the EU regulatory landscape and design the optimal regulatory strategy for the EU submission. We provide support in communication with the regulatory authorities through scientific advice procedures, including preparation of the necessary documents, choice of the experienced authority and case presentation at the scientific advice meeting.
Marketing authorisation support
We assist and council our clients during EU marketing authorisation procedure by preparing responses to the deficiency letters and advising on the optimal approach to the agency comments on the submitted dossier. In case of referrals, we provide full support from company´ position, presentation and case defence at the oral explanation session.
Medical writing
Medical writing is a communication channel between the company and the regulatory authority. To ensure clear and effective discussion, written documents submitted for assessment must convey clear and convincing story about the product under assessment and development as a whole. We offer medical writing services of high quality, with the aim to minimise the number of questions from the authority. We are experienced in writing non-clinical and clinical overview, briefing book for the scientific advice, responses to deficiency letters or paediatric investigation plan.
Dossier audits
For our clients outside EU, or those engaged in in-licencing activities, we offer high-quality dossier audits and qualified opinion on the fitness of the dossier for the EU registration. We audit the dossier not only from the formal point of view, but also compare the development against current EU regulatory guidelines, thinking and practices, as well as in-depth data analysis. We also perform gap analysis and provide recommendation for the optimal way forward.
Training
We offer tailor-made training sessions focused on clients´ specific needs. The training can be designed to cover specific topics, or general approaches and principles of drug development and regulatory requirements. Training is usually compiled of two parts: theoretical background and practical case studies. We aim to keep training sessions interactive and we encourage discussion for optimal results and best possible application of gained knowledge into practical work and real-life projects.
Clinical development
Design of the clinical development plan can be challenging for companies seeking to market in different jurisdictions, or those less familiar with EU requirements of the clinical data for different products. We advise on the best possible path to generating the data that will enable meaningful regulatory assessment and successful marketing authorisation. We are also experienced with global developments aiming to market in EU and we design bridging strategies from global to EU-specific requests.
Collaborations
To provide tailor-made solutions for our clients, we collaborate with a range of experts specialized in different area of regulatory science and drug development. In this way we are able to extend our services to include topics related to pharmacovigilance, quality, dissolutions, biowaivers, data mining or regulatory operations, data fraud detection, and thus provide a full range of services to accommodate each client´ s specific needs.