Are You Looking to Improve Your Company’s Regulatory Compliance Profile?
Today’s pharmaceutical and medical device industry executives are challenged with creating strong, compliance-centric cultures within an ever-expanding complex global organizational structure. As regulators begin to collaborate and use software tools to identify organizations with compliance weaknesses, it becomes of increasingly important to stay abreast of current industry compliance requirements. CTI’s Regulatory Compliance Services can help keep you current so your organization can prepare for the next regulatory inspection.
Inspection findings are just one reason to stay compliant. Executives are also beginning to recognize that “Compliance,” differentiated from “Quality,” is a critical competency for maintaining a company’s competitive position, assuring customer goodwill, achieving organizational competency, and most importantly maintaining the highest possible quality in their manufactured products. Demand for CTI’s compliance consulting services has been increasing because growing numbers of proactive executives are making “Compliance” an integral part of their plan in the journey towards operational excellence.
Regulatory expectations are strict and are codified in regulations and standards (for example., GMP’s-21 CFR 210/211- and or the Quality System Regulation – 21 CFR 820). Regulated companies must comply with the current regulatory expectations or suffer adverse business impacts. These impacts include: delayed new product approvals, withheld distribution of product, lost revenue/market share, falling stock prices, fines, cancelled government contracts, product recalls, litigation, consent decrees, warning letters, and, worst of all, adverse events leading to patient harm.
Regulatory Compliance Consultants
The mission of CTI’s Compliance Consulting Group is simple: To help our clients achieve improved compliance and better manage—in a cost-effective, integrated manner—the risk and potentially negative impacts of regulatory enforcement.
To do this, CTI develops and delivers customized and implementable compliance strategies, plans, processes, policies and procedures that build, enhance, evolve and transform the effectiveness of each client’s Quality Management System. CTI has subject matter experts with the experience required to deliver highly-customized compliance solutions that address the specific needs of each client. Our solutions are innovative because our subject-matter experts exhibit the following key skills and attributes:
- Thorough understanding of the current regulatory compliance environment, established industry standards, and implementable best practices
- Industry-relevant certifications, by recognized authorities on quality and compliance
- Proven expertise in a wide range of regulated production environments
- Drive toward creativity and innovation to provide cost-effective, implementable solutions
- Strong sense of urgency and ownership to achieve results as soon as practically possible
- Willingness to take the time to work with clients to assure understanding of the regulatory requirements
- Constructive attitude to help lead, drive and perform the necessary remediation work
Our Regulatory Compliance Services Include:
- Internal quality system/GMP audits (based on clients’ desired scope)
- Remediation planning, execution and project management
- Assistance managing regulatory inspections
- Guidance preparing responses to regulatory findings
- GMP training
- Design and development of Quality Management Systems
- Mock Regulatory Inspections (focused on the regulatory bodies of client choice)
- Design and authorship of quality records and procedures (e.g. SOPs, investigations, CAPAs, DHF, forms, change records, etc.)
- Preparation of Regulatory Filings
- Validation Audits / Program Assessment
- Validation Master Planning
- Serialization (Pharma – DSCSA) / Unique Device Identification (Devices)
The FDA’s focus on key quality system elements (such as CAPA, Process Change Control, Management Controls, Design Controls, etc.) makes it easier for the FDA to identify core compliance weaknesses. Systems found to inadequately manage any of the key areas lead regulators to conclude that a company exhibits systemic problems. These systemic problems will lead the regulator to pursue enforcement actions.
Compliance Team can help you avert enforcement action because we have developed an audit tool tailored to assess compliance FDA and ISO requirements. This tool will quickly uncover compliance gaps and helps to identify the areas of greatest compliance-risk. The high-risk areas can then be prioritized for remediation. CTI can modify this tool to focus on each company’s compliance objectives. Whether your goal is continual improvement or remediation of a known issue, Compliance Team is there to guide you toward progress every step of the way.