Medfiles USA advances a range of regulatory services from strategic consulting to documentation support and CMC expert services to help bridge the complexities of the ever-changing regulatory landscape. Our highly educated team has on average 10+ years of experience in the regulatory space, both within the pharmaceutical industry and from an authority perspective. Our experienced maintenance team offers comprehensive product maintenance services, as well as broad experience for pharmaceutical chemical documentation needs and esubmissions, these activities are highly suited to our sphere of regulatory capabilities.

Medfiles USA Service Offering:
Strategic Regulatory Consulting

  • Assess regulatory strategy and consult towards optimum path forward
  • Assist with design of clinical development plan
  • Support protocol development, review, and finalization
  • Provide oversight and coordination of regulatory operations, meeting request letter and briefing document, development of general investigation plan, US Agent services, ESG gateway related services, regulatory project management, mock rehearsals for pre-IND meetings and support at pre-IND meeting (attendance and post-meeting coordination with FDA) in cooperation with third party partners

Regulatory Submissions

  • Review documentation and perform gap analysis with evolving requirements

CMC Expert Services

  • Marketing authorization applications, including Module 3 documentation, quality overall summaries, requests for supplementary information and dossier evaluation or gap analysis
  • Consultation and classification of variations along with writing of documentation
  • Annual reports
  • Documentation for clinical trial applications (IND, IMPD) as well as ASMF, DMF, and CEP documentation
  • Validation protocols and reports
  • Consultation and training

Other Services

  • Project Management and Technology Transfer Services
  • Drug Development Strategies
  • Regulatory Intelligence
  • Medical Writing
  • Clinical Consulting
  • Quality and Compliance Support