Regulatory Affairs and Operations

Regulatory experts at MMS are adaptive, organized, and equipped with vast regulatory knowledge.

MMS has a proven regulatory track record, ensuring compliance of the submission to ICH and regional specifications.

Regulatory Affairs and Operations

Industry-trained experts at MMS are skilled at managing, preparing, and submitting a diverse array of regulatory submissions to global health authorities, serving as an extension to the sponsor team. Throughout the product life-cycle, MMS experts provide high quality and region-specific regulatory submission support using validated document management systems, local expertise, and eCTD publishing systems.

During the submission authoring and compilation process, MMS proactively engages proven processes to streamline activities, incorporate cross-departmental efficiencies, and build multiple health authority applications in parallel to execute regulatory submissions across the globe. Tenured colleagues can anticipate regulatory issues and resolve them in a timely, detailed manner.

From preclinical to late-stage regulatory strategy and global alignment of submissions and dossiers, MMS provides:

  • Early-stage regulatory operations, including applying for application numbers, filing intent to submit applications, meetings and briefing packages support, and advisory meetings
  • Clinical development regulatory operations and global submissions of study authorization applications, including initial study applications and amendments; scientific advice submissions; special designation submissions like fast-track designation, and special protocol assessment requests
  • Marketing authorization and post-approval life-cycle management, including initial marketing authorization applications or amendments and the maintenance of approved marketing applications


Related Client Case Studies

Successful MAA Filing

Following a successful NDA submission, learn the story of how MMS executed a MAA filing in advance of the planned submission date, through a flexible model, strong partnership, and thoughtful planning.

Download the case study

Data Management
& Biostatistics

& Medical Writing

Drug Safety
& Pharmacovigilance

Quality & Compliance