We deliver programs focussed on your objectives, focussed on delivering success now, not trying to introduce other services or partner companies.
We have the necessary processes, procedures, and experience to lead you through this vital stage. We collaborate and consult with all relevant functions, designing your program with an ethos of constant communication and alignment.
It starts with helping you clarify your objectives for the program. We can then explain the different ways to achieve your aims in individual countries.
Once we’ve defined this regulatory strategy at a global or regional level, we develop local implementation plans for each country. We also start to tailor our SMARThub management system to you, helping us implement the program seamlessly.
We work with functions across your company to identify requirements, objectives and restraints
We investigate the linkages desired to your clinical research and commercialization programs
This is an iterative process using our experience of the issues and decisions that need to be taken.
We propose options and solutions based on our experience
We design both the global program and individual country elements to ensure regulatory compliance
We gain agreement to all the differing elements and then develop up a comprehensive project plan to ensure all objectives are met.
We work in partnership with the sponsor’s functional leads and project managers to crate and initiate the program
We regularly update all stakeholders and ensure alignment through the whole process
We drive towards successful initiation and ongoing management of the program.
We believe regulatory expertise is core to our business success and how we deliver focussed successful access programs. We have built up that regulatory knowledge across 25 years of supplying unlicensed therapies globally and we have company objective that 10% of all staff must be regulatory professionals to ensure that knowledge, approach and culture flows through the whole company.
Our regulatory team is fully integrated into the EAP project management group.
Executive Vice President - Medicines Access
Head of Regulatory Affairs
Regional Sales Manager – MENA region