The Compliance Group, Inc. was founded to provide regulatory and technical expertise to manufacturers of Drug Products, and Medical Devices. With our extensive experience in the fields of Pharmaceutical Processes, Quality Assurance and Regulatory Affairs we assist companies to comply with the FDA's regulations. The Compliance Group, Inc. provides hands-on expertise in Product and Process Development, Compliance and Validation Programs.

Whether your business is R&D, pilot-scale, or full-scale production, you can benefit from the broad experience offered by The Compliance Group, Inc.: Training, Regulatory Compliance, Validation, Product and Process Development.

FDA Liaison Activities

Assistance with responding to FDA Warning Letters, 483s, and Implementation of Corrective Action Programs.



Assessment / Audit Approach

Our assessments and audits follow a defined path:

A regulatory reference list defining the agencies and applicable laws, regulations, and industry practices from
the latest publications your system or area will be assessed against.
Each item within these regulations is then defined in a tabular format.
Through a detailed review of your systems and documentation, our reviewers assess the quality of your
operation.
The assessment will define the gaps or non-compliance issues and rate the finding against a point numbering
system.
The numbering systems will layout the level and area of non-compliance (documentation, training, quality
reviews, engineering and so on).
The outcome is presented in a graphical format acknowledging problem areas.
The items identified during the assessment will be followed up with meetings and tracking of punch list items
assuring that all findings are corrected.



Types of Assessments / Audits

Quality Assurance Programs

Review of Change Control / Configuration Management Programs
Document Control Systems
Batch Record Review

Regulatory Compliance Assessments may include:

Evaluation of Quality Systems
Internal cGXP Audits
cGMP Compliance Evaluation
Review of Validation Studies, and Documentation
Review of Investigation Reports and Resolution of Compliance and Quality Problems
Compliance Review of Facilities and Equipment
Review of Employee Training Programs/ Vendor Qualifications
Software Assessment Against IEEE Standards
Computer Systems Validation
System Security, Vendor Audits
SOP, Programs and Corporate Policies
Analytical Laboratories Audit