Meridan Consulting
Meridan Consulting is a global regulatory compliance consulting firm specializing in FDA-regulated industries. Owned and operated by a former FDA Investigator, the company consists of experienced former FDA Investigators and industry experts. Their mission is to help companies stay inspection-ready, obtain FDA approvals, and maintain compliance through tailored consulting, training, and certification programs. They focus on investigation of data integrity breaches, remediation of deficiencies, and providing strategic guidance to ensure successful regulatory outcomes.
Industries
Nr. of Employees
medium (51-250)
Meridan Consulting
Services
483/Warning Letter/Import Alert Support
Preparation of regulatory responses, development of remediation strategies, and support to achieve acceptable compliance outcomes including removal from import alerts or lifting of Warning Letters.
Audits & Assessments
Pre-approval, vendor, supplier, and due diligence audits to evaluate facilities, data integrity, quality systems, and compliance risk.
Registered U.S. Agent / FDA Liaison
Designation as U.S. Agent for foreign establishments to manage communications and respond to FDA inquiries on behalf of the client.
Quality System Development
Design and implementation of quality management systems and procedures tailored to company operations to meet regulatory expectations.
Training Programs
Customized, on-site training programs for personnel and management on GMP applicability and company-specific procedures; training materials become the client's property.
Auditor Certification
Certification program combining classroom instruction and supervised field audits to qualify internal auditors.
483/Warning Letter/Import Alert Support
Preparation of regulatory responses, development of remediation strategies, and support to achieve acceptable compliance outcomes including removal from import alerts or lifting of Warning Letters.
Audits & Assessments
Pre-approval, vendor, supplier, and due diligence audits to evaluate facilities, data integrity, quality systems, and compliance risk.
Registered U.S. Agent / FDA Liaison
Designation as U.S. Agent for foreign establishments to manage communications and respond to FDA inquiries on behalf of the client.
Quality System Development
Design and implementation of quality management systems and procedures tailored to company operations to meet regulatory expectations.
Training Programs
Customized, on-site training programs for personnel and management on GMP applicability and company-specific procedures; training materials become the client's property.
Auditor Certification
Certification program combining classroom instruction and supervised field audits to qualify internal auditors.
Expertise Areas
- Regulatory compliance for FDA-regulated pharmaceuticals
- cGMP remediation and corrective action programs
- Data integrity investigation and remediation
- Quality management system (QMS) development and implementation
Key Technologies
- Good Manufacturing Practices (GMP) compliance frameworks
- Data integrity auditing and forensic review
- Quality management systems (QMS) design
- Regulatory inspection readiness and pre-approval review methods