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Regulatory, Quality, Clinical & Medical Affairs Consulting Services

Global Regulatory Affairs

Global Clinical Strategy & Development

Global Regulatory Affairs

  • Global Regulatory Submissions / Licenses (Drug, Biologic, Medical Device & Combination Products)
  • Global Regulatory Intelligence
  • Managing & Leading Pre-Submission Agency Meetings and Post-Meeting Follow-up Actions & Strategy
  • Global Regulatory Requirements (Pre-Market & Post-Market) 
  • Global Regulatory Strategy
  • Promotional Review
  • Labeling Review 
  • D

  • Global Regulatory Submissions / Licenses (Drug, Biologic, Medical Device & Combination Products)
  • Global Regulatory Intelligence
  • Managing & Leading Pre-Submission Agency Meetings and Post-Meeting Follow-up Actions & Strategy
  • Global Regulatory Requirements (Pre-Market & Post-Market) 
  • Global Regulatory Strategy
  • Promotional Review
  • Labeling Review 
  • Development Strategy
  • Pharmacovigilance & Medical Device Reporting Requirements

Speak to our Experts
Quality Compliance

Global Quality Compliance

Global Clinical Strategy & Development

Global Regulatory Affairs

  • Quality System Requirements (i.e. FDA QSR, QSIT, ISO 13485, cGMP's, GCP's etc.) 
  • Quality System Development (Procedures, SOP's etc.)
  • Quality System Compliance
  • Process, Procedure & Record Remediation
  • Inspection & Audit Preparation
  • Risk Management
  • Design Controls
  • Post-Market Field Action Determination Support
  • Field Corrective Actions & Field Safety

  • Quality System Requirements (i.e. FDA QSR, QSIT, ISO 13485, cGMP's, GCP's etc.) 
  • Quality System Development (Procedures, SOP's etc.)
  • Quality System Compliance
  • Process, Procedure & Record Remediation
  • Inspection & Audit Preparation
  • Risk Management
  • Design Controls
  • Post-Market Field Action Determination Support
  • Field Corrective Actions & Field Safety Corrective Actions Support
  • Supplier Quality Agreements 
  • Supplier Quality Requirements
  • Quality System Audits
  • Supplier Quality Audits
  • Endpoint Adjudication Committee Audits
  • GCP Audits


Schedule A Consultation

Global Clinical Strategy & Development

Global Clinical Strategy & Development

Global Clinical Strategy & Development

  • Clinical Support (Drug, Biologic, Medical Device & Combination Products)
  • Clinical Trial Strategy (Phase I, Phase II, Phase III & IV)
  • Clinical Trial Protocol Development
  • Clinical Trial Monitoring & Compliance
  • Safety Monitoring Committee (Safety Review Board)
  • Medical Monitoring
  • Investigator Brochures
  • Statistical Considerations, Analysis Planning and Reporting

Contact Us

Medical Affairs

Inspection Readiness, Responses & Remediation

Global Clinical Strategy & Development

  • Commercial Strategy Support
  • Key Opinion Leader Development
  • Publication Strategy & Planning
  • Promotional Review

Schedule An Appointment

Inspection Readiness, Responses & Remediation

Inspection Readiness, Responses & Remediation

Inspection Readiness, Responses & Remediation

  • FDA Inspection Readiness
  • Pre-Inspection Gap Analysis and Remediation
  • Mock FDA Inspection
  • Lead and/or Support FDA Inspections
  • 483 / Warning Letter / Consent Decree Responses, Strategy, Planning, Remediation & Corrective and Preventive Actions
  • OUS Inspection / Audit Support (i.e. EU Notified Body, PMDA/MHLW, CFDA, Health Canada etc.)
  • Conduct Internal Quality  Audits

Speak To Our Experts

FDA U.S. Agent & Official Correspondent

Inspection Readiness, Responses & Remediation

Inspection Readiness, Responses & Remediation

FDA U.S. Agent 

(Foreign Establishments)

  • Assist in Communications with FDA & Establishment
  • Respond to FDA Questions Regarding Establishment's Products
  • Assist FDA in Scheduling Inspections of the Establishment
  • FDA May Provide Information or Documents to the U.S. Agent (if Unable to Contact the Establishment)


FDA Official Correspondent

  • Responsible

FDA U.S. Agent 

(Foreign Establishments)

  • Assist in Communications with FDA & Establishment
  • Respond to FDA Questions Regarding Establishment's Products
  • Assist FDA in Scheduling Inspections of the Establishment
  • FDA May Provide Information or Documents to the U.S. Agent (if Unable to Contact the Establishment)


FDA Official Correspondent

  • Responsible for Annual Establishment Registration and Device Listings.
  • Receive Correspondences from the FDA Involving the Owner/Operator and any of the Firm's Establishments
  • Updating the Facility Address, Deleting or Activating Device Listings, Adding Initial Importers and Managing the Account through FURLS (FDA’s Unified Registration and Listing System)  


Contact Us

Regulatory, Quality & Clinical Pre- & Post-Acquisition & Pre-Divestiture Support

Regulatory, Quality & Clinical Pre- & Post-Acquisition & Pre-Divestiture Support

Regulatory, Quality & Clinical Pre- & Post-Acquisition & Pre-Divestiture Support

  • Regulatory, Quality & Clinical Functional Support with Pre-Acquisition and Pre-Divestiture Assessments
  • Regulatory, Quality & Clinical Functional Support with Post-Merger Integration Activities

Schedule A Consultation

Program Management & Business Excellence

Regulatory, Quality & Clinical Pre- & Post-Acquisition & Pre-Divestiture Support

Regulatory, Quality & Clinical Pre- & Post-Acquisition & Pre-Divestiture Support

  • Project Planning
  • Project Budgeting
  • Resource Requirement Assessments
  • Strategies on Effective Organizational Structure
  • Risk-Based Approach
  • Total Quality Management
  • Balanced Business Scorecards
  • Key Performance Indicators
  • Benchmarking

Speak To Our Experts

Training

Regulatory, Quality & Clinical Pre- & Post-Acquisition & Pre-Divestiture Support

Training

  • Understanding and Interpreting FDA & OUS Global Regulatory Requirements (includes EU MDR)
  • Quality System Requirements (i.e. FDA QSR, QSIT, ISO 13485, cGMP's, GCP's etc.)
  • Risk Management
  • Design Controls
  • Customer Complaints
  • Medical Device Reporting
  • Pharmacovigilance Reporting
  • Corrections & Removals (i.e. Field Safety Corrective Actions)
  • CAPA
  • Management Responsibility

Schedule A Training Session

The Eriah Group

P.O. Box 31894, Independence, OH 44131

(440)479-0511

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