Regulatory Consulting & Strategy Services

We’re more than just an FDA compliance consultant! At A Wright Path, we view our clients as business partners and work with you to develop strategies that best benefit your business. Our partnership is built on excellence, integrity, passion and social conscience. As your business partners, we stay abreast of today’s quickly changing regulatory requirements to take your business into the future. Our regulatory and quality consulting services will help you gain clearance, maintain compliance and improve your overall quality. Here’s how we’ll get your business on The Right Path, Right Now!

REGULATORY AFFAIRS

Expedite your product development and hit the global marketplace with maximum regulatory compliance in FDA Regulatory Submissions, CE marking and more — while avoiding hurdles.

  • Regulatory Intelligence
  • Regulatory Strategy
  • Worldwide Registrations and Approvals (Asia / Australia / China / Japan / Latin America) – Medical Devices / Combination Products / Cosmetics
  • Establishment of Registration and Device Listing
  • Designated U.S. Agent for Foreign Manufacturers
  • IDE Application, IDE Supplement and Annual IDE Reporting
  • CE Marking / European Directive (Technical File / Design Dossier)
  • 510 (k) Regulatory Submissions – Traditional, Special and Abbreviated
  • 513 (g) Request
  • de Novo Petition
  • HUD and HDE Application
  • FDA (Food and Drug Administration) Q-Sub Process
  • CE Marking (Technical File/Design Dossier/STED)
  • CMDR Licensing – Canada
  • Regulatory Standards Assessment / Gap Analysis
  • Regulatory Deficiencies (483 / Warning Letter / Consent Decree)
  • Liaison and Communications with Regulatory Agencies
  • Regulatory review of Labeling and Marketing Materials
  • Letter to File
  • FDA Inspection, Certificates and Permits

A Quality Management System (QMS) defines how a company will achieve the creation and delivery of the products and services. As a regulatory and quality consulting firm, A Wright Path will aid in setting up and maintaining your QMS to meet your requirements and global regulations.

QUALITY MANAGEMENT SYSTEMS (QMS)

Develop, implement and sustain your Quality Management System for compliance with global regulatory requirements, including FDA regulations, ISO standards and Good Manufacturing Practices (GMP).

  • Quality Management System Development and Implementation
  • FDA Quality System Regulation (QSR)
  • MDD/MDR
  • MDSAP (Australia, Brazil, Canada, United States, Japan)
  • ISO 13485 (2016)
  • ISO 9001 (2015)
  • Cosmetics Good Manufacturing Practices (GMP) – ISO 22716
  • DAMAS Quality System – NADL
  • Other Global Regulatory Requirements
  • Quality System Support / Maintenance
  • Quality System Integration / Quality System Projects / Due Diligence
  • Standard Operating Procedures (SOP)

QUALITY ASSURANCE

Ensure all the planned and systematic activities are implemented within the quality management system to provide confidence in a quality product or service.

  • Manufacturing Process and Equipment Validation
  • pFMEA
  • Facility Qualification / Manufacturing Transfer Facility Qualification
  • Internal Audits
  • Gap Assessments / FDA / Regulatory Body Pre-Audit Preparation
  • Supplier Evaluation / Audits
  • FDA / Regulatory Body Mock Audit Inspections
  • Due Diligence Audit
  • QMS Training and Staff Development
  • Internal Auditor Training
  • DAMAS Training
  • Microbiology Assessment / Cleanroom Monitoring / Validation
  • Cleaning Process Validation and Assessment / Reusable Medical Devices
  • Medical Device Failure Analysis
  • Pre-Submissions and Pre-Market Notifications

The Right Path, Right Now implements and maintains your quality management system to consistently meet customer expectations and regulatory requirements.

DESIGN QUALITY ASSURANCE

Define global regulatory and customer requirements to ensure compliant products and patient safety.

  • Combination Products (Devices / Drugs / Biologics)
  • Medical Devices / Biologics / Consumer Products / Cosmetics
  • Project Management / Design Controls / Design Transfer / DHF
  • Usability and Human Factors (IEC 62366 and ANSI / AAMI HE75)
  • Safety Risk Management (ISO 14971)
  • Design Assurance / Verification / Validation
  • External Standards and Guidance Maintenance
  • UDI (Unique Device Identification)
  • Sterilization Validation (EO, Gamma, Steam and HPV)
  • Biocompatibility Testing and Risk Assessment
  • Packaging Validation and Sterile Packaging Validation (ISO 11607) 0 (New, Modified, Adoptions)

We offer the Right Path, Right Now® to define global regulatory and customer requirements to ensure compliant products and patient safety.

CLINICAL TRIAL & STRATEGY

Expedite your product development and hit the global marketplace with maximum regulatory compliance in Clinical Trial Strategy, Clinical Trial Monitoring, Clinical Trial Regulatory Submissions and more.

  • Clinical Trial Strategy — Feasibility/Pilot and Pivotal/Multi-Center
  • Protocol Development and associated clinical trial documents (case report forms, informed consent forms, clinical monitoring plans)
  • Clinical Protocol Amendments
  • IRB Approvals
  • IDE Applications, Supplements and Annual/Periodic Reporting
  • Informed Consent Requirements
  • Study Design
  • Study Execution and Monitoring
  • Managing Clinical Trials (Domestic and International)
  • Clinical Evaluation Process — Clinical Evaluation Reports (CER), MEDDEV 2.7/1 Rev 4 – CEPs, CERs, PMCF Plans, PMCF Reports
  • Safety Activities — Post-Market Surveillance/Complaints, Health Risk Assessments (HRAs), MDRs
  • Selection and management of CROs, core labs, and other vendors
  • EDC database design, validation, and management

The Right Path, Right Now implements and maintains your quality management system to consistently meet customer expectations and regulatory requirements.

Entities like medical device companies and combination product manufacturers must complete post-market surveillance to monitor FDA-regulated items after clearance.

POST MARKET SURVEILLANCE (PMS)

Monitor the performance of a product with a collection of post-market processes and activities.

  • Complaint Handling
  • Recall Crisis Management
  • Adverse Event Reporting
  • Post Market Surveillance Activities
  • Post Market Clinical Follow-up Studies (PMCF)

REMEDIATION ACTIVITIES

Implement a plan to define remediation activities, determine risk, discover root cause and design corrective actions following warning letters, audits (internal, FDA or regulatory bodies) or gap assessments.

  • QMS – Quality Management System
  • DHF – Design History File
  • Technical Documentation – Technical File, Design Dossier, STED
  • 510 (k) Catch Up and Assessment
  • Quality Plan and Associated Risk
  • Root Cause and CAPA

We offer the Right Path, Right Now® to ensure a quality plan to define remediation activities, root causes, and corrective actions as well as risk during remediation activity.