What we offer

We provide our clients with the benefit of two decades of industry expertise, enhanced by our extensive Regulatory Affairs network. Our strengths lie in team building and leader sourcing across all facets of the Regulatory landscape. We have supported a wide array of Life Science companies—including pharmaceuticals, biotech firms, generics, CROs, medical devices, animal health, and consultancies—across various contexts. This includes assisting start-up biotech companies with contract Regulatory support and helping them form permanent regulatory teams, as well as building teams within established CROs that focus on early-phase development and lifecycle management of existing products. Additionally, we collaborate closely with specialised Regulatory consultancies to pinpoint the specific skill sets required to address their unique challenges.

We collaborate with our clients to fill both contract and permanent Regulatory Affairs positions in the following areas:

Early-phase regulatory work: CTAs, PIPs, scientific advice, agency meetings, BLAs etc
Full lifecycle regulatory activities
Post-marketing/post-approval activities: MRP, DCP, MAAs etc
CMC: pre- and post-approval
Regulatory operations: publishing, RIM systems etc
Regulatory policy/intelligence
Therapy area-specific roles
Medical Devices RA/QA

We help you move your company forwards faster, more efficiently and with less workload on yourself. Contact us if this sounds like something you would like do.