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
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- 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
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
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
Medical Affairs
Inspection Readiness, Responses & Remediation
Global Clinical Strategy & Development
- Commercial Strategy Support
- Key Opinion Leader Development
- Publication Strategy & Planning
- Promotional Review
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
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)
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
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
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