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
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.
Pre-approval, vendor, supplier, and due diligence audits to evaluate facilities, data integrity, quality systems, and compliance risk.
Designation as U.S. Agent for foreign establishments to manage communications and respond to FDA inquiries on behalf of the client.
Design and implementation of quality management systems and procedures tailored to company operations to meet regulatory expectations.
Customized, on-site training programs for personnel and management on GMP applicability and company-specific procedures; training materials become the client's property.
Certification program combining classroom instruction and supervised field audits to qualify internal auditors.
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.
Pre-approval, vendor, supplier, and due diligence audits to evaluate facilities, data integrity, quality systems, and compliance risk.
Designation as U.S. Agent for foreign establishments to manage communications and respond to FDA inquiries on behalf of the client.
Design and implementation of quality management systems and procedures tailored to company operations to meet regulatory expectations.
Customized, on-site training programs for personnel and management on GMP applicability and company-specific procedures; training materials become the client's property.
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
News & Updates
In 2014, served as remediation consulting company for an Indian-based finished dosage manufacturing firm that received a 483 for analytical laboratory data integrity violations. Site clearance was received within 3 months.
In 2015, awarded ‘Specialty Service Provider of the Year’ for a US-based Fortune 500 company for projects related to supply chain security and temperature control.
In 2016, served as remediation and product assessment consulting company for an Indian-based API and finished dosage manufacturing company placed under import alert for data integrity violations. Over 150 batches assessed, remediation strategy presented to FDA, and import alert lifted.
In 2017, designed a certification program for an Indian-based finished dosage manufacturing company under import alert for data integrity violations. Remediation deemed satisfactory and import alert lifted.
In 2014, served as remediation consulting company for an Indian-based finished dosage manufacturing firm that received a 483 for analytical laboratory data integrity violations. Site clearance was received within 3 months.
In 2015, awarded ‘Specialty Service Provider of the Year’ for a US-based Fortune 500 company for projects related to supply chain security and temperature control.
In 2016, served as remediation and product assessment consulting company for an Indian-based API and finished dosage manufacturing company placed under import alert for data integrity violations. Over 150 batches assessed, remediation strategy presented to FDA, and import alert lifted.
In 2017, designed a certification program for an Indian-based finished dosage manufacturing company under import alert for data integrity violations. Remediation deemed satisfactory and import alert lifted.