Regulatory Solutions

Linkfield Regulatory Solutions provides 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

Reach out to learn more about how we can collaborate with your organisation