Regulatory services dossier submission

In this environment of rapid change and ever increasing demands, companies need to work smarter than ever before, especially in the global arena. Regulatory partnership is a key strategy that can help Pharmaceutical, Biotechnology, Medical Device, and Nutraceutical companies to focus on their core competencies and innovations. Source Life science consulting llc services offers a comprehensive portfolio of Regulatory services, which comprises of best practices and solutions.

With years of rich experience, we can help you solve the Regulatory puzzle with innovative and customized solutions. We have a strong team of dedicated professionals with many years of industry and agency experience, who can tailor the project plans to meet different regulatory requirements. We have built a successful track record of timely and extensive approvals.

  • Regulatory Strategy.
  • Local regulations & compliance requirements.
  • Product Classifications.
  • Data requirements.
  • Approval Pathways.
  • Design controls consulting & implementation.
  • Regulatory Writing.
  • Product Approval /Marketing Application.
  • 510K, PMA, CE Marking consulting, Emerging and ROW market applications.
  • Technical Files & Dossiers.
  • Plant master files, device master file, etc.
  • Clinical Comparison Summaries.
  • Clinical Trial Applications.
  • IDEs, CTAs, Ethics approvals, etc.
  • Annual Reports / Supplements.
  • Case processing, safety reports, supplements, renewals,Submission management.
  • Paper / Hybrid / Electronic Application.
  • FDA, EMA, MHRA, PMDA, DCGI, etc.
  • Authorized Agent / Establishment Registration.
  • Device Listing & Licenses Management.
  • Regulatory Information Management.
  • Agency Responses & Meetings.
  • Audit preparedness.
  • Local & Global Compliances consulting and support.
  • Quality management Systems implementation and validation.
  • QSRs, CFR part 11, part 820, ISO 13485, ISO 14971, IECs, ASTMs, etc.
  • Advertising and Labeling compliance; review and design (IFUs, e-Labeling, package artwork, etc).
  • Internal Trainings Contract RA / QA team In-sourcing.

Our experts are connected to deliver integrated solutions across US, Europe, ROW, etc. with detailed knowledge of the different local submission processes.