our
services
When you need been there, done that
regulatory expertise embedded in your team
Interim Heads of Regulatory
Our interim leaders, all experienced former heads of regulatory affairs, are ready to step in and seamlessly take the helm of your regulatory function. Whether planned or unexpected, the departure of your Vice President of Regulatory or Chief Regulatory Officer can spell uncertainty and potential disruption for your company's development plans and relationship with regulators. Minimize the impact by quickly inserting an experienced regulatory leader to ensure seamless execution of regulatory plans and strategies, maintain a senior regulatory voice, and support your regulatory team to ensure retention.
We also support emerging companies heading into the clinic but not yet ready for a fulltime head of regulatory.
Global Regulatory Strategists
All of our regulatory strategists are highly-experienced global regulatory leads are adept at quickly embedding into your organization and prepared to independently assume leadership of your program's regulatory strategy, activities, and regulator relationships. Our consultants assume the role at any stage of development and can deliver regulatory clarity by assessing the regulatory landscape and developing a solid global regulatory strategy. As the regulatory lead on your program team, they drive submission preparation, including INDs and marketing applications, lead health authority interactions, and evaluate special designations and other regulatory vehicles to accelerate the development and approval of your products.
Regulatory Project Managers
Our team of seasoned regulatory project managers have extensive experience managing all types of submissions, including INDs, CTAs, NDAs, BLAs, and MAAs and related advisory committee meetings. Collaborating closely with your regulatory leads and program team members, our versatile and collaborative RPMs will develop and oversee comprehensive timelines for submissions and overarching regulatory programs to ensure that your organization's regulatory goals are achieved. We will create informative dashboards that effectively communicate the progress of your submission and guide your team towards high-quality and timely submissions.
Filing Leads and Support
At no other time in your company’s development have strategic clarity, operational excellence, and strong leadership been more needed and more rewarded than your first BLA or NDA. Submitting a complete and high-quality marketing application as soon as possible has enormous benefits for your company and your patients. Give your team the support and guidance of consultants who have unrivalled expertise leading NDA and BLA teams to success. We integrate into your team and leverage your in-house talent. We use a proven approach and tools for planning and preparing marketing applications and we can turn a formidable task into a confident drive to success. Read about our approach in Elements of NDA & BLA Readiness
Advisory Board
Access a high-level and seasoned network of experts to review and provide opinions and guidance on your most challenging development questions and plans. Benefit from the insight of the most experienced fit-for-purpose colleagues in our industry on an ad hoc basis as needed to assess gaps, advise, and build confidence in your strategy.