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REGULATORY & COMPLIANCE CONSULTANTS DELIVERING CUTTING-EDGE EXPERTISE

Griffin Global Systems (GGS) offers a complete suite of regulatory and compliance consulting services, from individual consultants to project teams to strategic outsourcing. Our individual consultants and project teams deliver the business knowledge and hard-to-find technical expertise our clients need on their projects. Our consultants can fill knowledge gaps on current teams, or work independently under our clients' direction as quality assurance managers, regulatory affairs associates and validation engineers.


CORPORATE OVERVIEW - Capability Statement

At GGS, we provide our clients with the capacity, experience, and depth and breadth of expertise of a "big" firm, along with the flexibility and personalized attention of a "small" firm. With an extensive database of nationally-traveling Quality and Regulatory Compliance consultants, we are ready at a moment's notice to provide you with highly experienced and seasoned professionals who are prepared and eager to add tremendous value to your teams. Our consultants are experts in all the latest standards, trends, and issues facing Quality and Regulatory teams.

Expertise

Griffin's experienced consultants assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, compliance, auditing, and statistical projects, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations. Our consultants' expertise includes:

  • Quality Assurance & Quality Engineering: Development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control. Methodology, policy, and procedure development. Gap/Risk assessment. Recalls, MDR's and complaint handling. Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 1, quality systems, vendors, and IT compliance.
  • Regulatory Affairs: Writing submissions, documentation, and remediation including 510(k) submissions, AER's, PMA's, IDE, remediation/resolution management, technical papers and complaint handling.
  • Validation: Developing Standard Operating Procedures (SOP), validation protocols (IQ, OQ, PQ), and validation master plans. Conducting validation executions and writing validation reports. Computer systems, software, process, cleaning, methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11.
  • Statistical Analysis: Statistical design and analysis for all phases of clinical trials, from the beginning planning stages through study completion and report preparation.

Contact

Thank you for your interest. For questions or comments, please use the information listed here. We look forward to hearing from you soon.

Phone
(855) 747-4334

Address
600 Sandtree Dr., Suite 212
Palm Beach Gardens, FL 33403

Service Area
Nationwide

Our Location

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