EG Consulting, Inc., provides full program strategic, regulatory, and technical advice to the pharmaceutical and biotechnology industry. We provide support for developing, directing, and implementing the global regulatory strategy, objectives, policies, and programs pertaining to the development of drug and biological products. As the global regulatory lead, EG Consulting, Inc. can provide product candidate life cycle support, which includes the leadership of regulatory strategy for multiple programs that extend globally from candidate discovery through registration.

EG Consulting, Inc. has in-depth knowledge of programs to facilitate and expedite development of new drugs to address unmet medical needs in the treatment of serious and life-threatening conditions and rare diseases. We have expertise in applications for orphan product designation, fast track designation, breakthrough therapy designation, accelerated approval, priority review designation, and expanded access programs. Each of these programs are intended to help ensure that therapies for serious or rare conditions are approved and available to patients as soon as results support that the benefits of the therapy justify their risks.

Services

  • Lead development of global regulatory strategy in close collaboration with development disciplines, including quality, nonclinical and clinical
  • Preparation and management of regulatory and project development strategy and plans, identification of critical tasks, preparation and maintenance of project timelines, oversight and technical expert coordination, project reporting to team members, senior management, and Board of Directors
  • Single point of contact and accountability for regulatory strategy and regulatory affairs
  • Lead technical discipline experts to drive global regulatory strategy and meet milestones
  • Develop and maintain electronic project document management system, including due diligence data room to support funding and other business transactions

  • Communication and understanding of FDA and global health authority policies and procedures
  • Pre-IND, End-of-Phase 2, Pre-NDA/BLA and Scientific Advice Meeting Preparation
    • Review and assessment of technical data to support product development program
    • Preparation of technical documentation to support meeting request and background materials
    • Lead interactions with FDA/health authority and meeting management on behalf of sponsor company
    • Manage meeting rehearsals and ensure sponsor readiness
  • IND/CTA Submission
    • Review and/or preparation of all technical data
    • IND/CTA preparation and review in the common technical document (eCTD) format
    • Investigational Medicinal Product Dossier (IMPD) preparation
    • Document production
    • Electronic document management and submission
    • Interactions with FDA and global health authorities on behalf of sponsor company
    • Response to FDA and health authority regulatory actions and requests for additional information
    • Preparation of all IND/CTA amendments, safety reports, and annual reports, including Development Safety Update Reports (DSUR)
    • Support clinical affairs as needed to ensure alignment of regulatory submissions with clinical operations, trial initiation, and availability of clinical supplies
    • Clinical trial database registration and maintenance (www.clinicaltrials.gov)
  • Expedited Development Programs for Serious and Rare Conditions
    • Orphan Product Designation
    • Qualified Infectious Disease Product Designation (QIDP)
    • Fast Track Drug Designation
    • Breakthrough Therapy Designation
    • Accelerated Development and Approval
    • Priority Review Designation
    • Expanded Access and programs for other treatment options
    • Special Protocol Assessment
  • Pediatric Study Plans and Pediatric Investigation Plans (PIP) and waivers
  • NDA and BLA Submission
    • Review and/or preparation of all technical data
    • Assist in application preparation and review
    • Electronic document management and submission
    • Interactions with FDA and other health authorities on behalf of sponsor company
    • Response to FDA and health authority regulatory actions and requests for additional information
    • Assist in preparation of application amendments and supplements
  • Drug Master File Review and Preparation

  • Assist business development team and CEO in management of potential partners reviewing assets for funding and/or business transaction
  • Data room selection, implementation and management to support due diligence and transition activities

  • Clinical protocols
  • Investigators Brochure
  • Study reports
  • Scientific reports
  • Regulatory documents

  • Train and mentor junior staff
  • Drug and biologics regulatory policies and procedures
  • Pharmaceutical drug and biologics development and regulation
  • Expedited drug and biologics development for serious conditions
  • Special topics (available upon request)