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Program Strategy & Design

At Smartway, we see regulatory strategy and program design as being totally integrated. Our regulatory team comes with deep knowledge of the various regulatory schemes and jurisdictions around the world.

We deliver programs focussed on your objectives, focussed on delivering success now, not trying to introduce other services or partner companies.

Strategy and design process

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.

Our regulatory team

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.

Meet the team

Robert Donnell

Executive Vice President - Medicines Access

Nicole Lyons

Head of Regulatory Affairs

Maysa Gamal

Regional Sales Manager – MENA region

Talk to the team