Regulatory Consulting


Global Management Consulting specializes in all types of Regulatory Consulting to meet each stage of compliance. We provide flexible international regulatory consulting services for all types of industries, for manufacturing, suppliers, laboratories and more.

Regulatory Consultants can handle multiple aspects no matter the stage your products, pre-market review, product control, or post market surveillance. Global Management Consulting consultants can provide and ensure compliance and develop strategies that represent your organization and regulatory compliance. Our consultants not only provide guidance but also provide training to your organization. Eliminate the carrying costs of long term high paid employees.

Ensure compliance with a regulatory expert liaison between your company and the contractor with Global regulatory regarding product clearance. Coordinate, prepare, and follow-up with international regulations substantial change notifications- defend your submission during the review process with and assist with securing market clearance or approval.

 

Regulatory Consulting Services


Global Management Consulting provides regulatory consulting services at each stage to ensure compliance. Pre-market review, product control, or post market surveillance our regulatory subject matter expertise can provide and ensure compliance.

  • Education/Training-Changes and developments in the regulatory industry;
  • Road Map-Construct a strategy to and outline framework to pre-market review, product control, or post market surveillance;
  • Conception & Development;
  • Establish Process & Procedures, Controls;
  • Documentation requirements-Identify, Design, implement;
  • Product Control- Outline regulatory requirements;
  • Submission Management;
  • Manufacturing Facility- Inspection guidelines requirements;
  • Packaging/Complaint Handling- Identify Evaluate outline and create or change current procedures;
  • Software – Data management, Validation, Security;
  • Post-market surveillance-Outlined in the quality system requirements, internal auditing.

 

Quality System Requirements


Global Management Consulting provides regulatory guidance to establish, design, and implement documentation requirements.