Regulatory Filing and Representation

Based on if the product is a drug, biologic or cell-based therapy and current stage of development, there are a variety of submissions that may be required by regulatory agencies in the US, Europe, Canada, and throughout the globe. Utilizing strategies designed to address regulatory concerns and minimize additional questions, our team reviews, prepares and submits documents required for appropriate regulatory pathways.

Our team has prepared and submitted hundreds of successful regulatory documents, including:

  • In-country representation and registration
  • FDA Establishment Registration
  • FDA US Agent for Foreign Establishments
  • EU Authorized Representative for Marked Drugs
  • Authorized Representative for Drug Trials in Europe
  • FDA/EMA Advisory Committee and panel preparation
  • Oral explanation preparation
  • Milestone FDA meetings (pre-IND, C, EOP 1/2, Pre-NDA/BLA and BPE)
  • Health authority responses to questions
  • Resolution and response to safety issues
  • Representation with FDA and National Competent Authorities
  • Scientific Advice (EMA) and argument development
  • Regulatory consulting
  • Regulatory intelligence and gap analysis for submission types
  • Global submission strategy and processes to achieve target markets
  • FDA 505(b)(2) assessment and plans
  • Orphan, Pediatric , Fast-track, Breakthrough, Gain Act Designations
  • Target product profiles and readability testing
  • Label development and negotiation
  • Oral explanations, agency hearings and meetings
  • Feasibility risk assessment
  • FDA and QMS Audits
  • Rescue and remediation compliance service
  • Advertising and promotional material review
  • Clinical SmartStudyTM study design, protocol development, and feasibility assessments
  • Site and patient feasibility assessments
  • Clinical site services, protocol development, startup, training and recruitment
  • Bridging studies to support reference and historical data
  • IRB/Ethics Committee filings and informed consent
  • Risk Evaluation & Mitigation Strategy (REMS) plans
  • Pricing and reimbursement studies
  • Drug Safety Monitoring Committees and safety surveillance
  • Scientific and medical advisory boards and thought leaders
  • Pre-submission support documents
  • New and Amended Drug Applications (NDA, ANDA)
  • Biologic License Applications (BLA)
  • Investigational New Drug Applications (INDs)
  • Document development, review and submissions
  • Competitive pipeline assessment, label and claims analysis
  • Label and package leaflets, user testing for readability
  • Message development and validation
  • Clinical and non-clinical summaries and expert reports
  • Media and advocacy relations
  • 513(g) Requests for Classification
  • Technical Files
  • Canadian License Applications
  • US FDA Quality System Regulation (FDA QSR) and ISO 13485.
  • QMS compliance: ISO 13485, and 21 CFR part 820
  • Strategic and tactical planning
  • Turn key project management and operations
  • Briefing document and advanced package preparation
  • Slide presentation and scripting
  • Slide composition, story boarding, indexing, and retrieval
  • Mock FDA Advisory committee meetings
  • Advisory committee profiling and intelligence
  • Speaker Training
  • Q&A preparation and training
  • Speaker, “Bullpen,” and media training
  • Provide and support KOL and experts
  • Meeting logistics and onsite management