Regulatory Affairs Services

Reach out now

Regulatory Affairs Services

At GLORAMP, we deliver end-to-end Regulatory Affairs support — from early development to post-approval — ensuring compliance, quality, and faster market access across the UK, EU, and global regions.

Strategy & Pathways​
  • Our experts design efficient regulatory strategies tailored to your product and market goals — navigating UK (MHRA) and EU routes including CP, MRP, DCP, and NP procedures, along with variations and renewals.
  • Comprehensive MDR and IVDR strategies, technical documentation authoring, and CE/UKCA planning — ensuring smooth certification and post-market readiness.
Regulatory Publishing & Submissions

Expertise across all submission formats and global procedures:

  • IND/CTA → MAA/NDA/BLA/ANDA lifecycle management
  • Baseline and global sequence submissions
  • eCTD publishing and validation on modern toolchains
  • Quality control aligned with authority specifications
Authoring & Regulatory Responses

Full authoring and review support for Modules 1–5, including:

  • Clinical and nonclinical overviews and summaries

  • CMC sections and variation documentation

  • Deficiency responses grounded in the best practices of leading RA publishers

Book a free call

Let’s talk! Book a free 30-minute call with a senior team member to explore how we can support your goals.

Reach out now