OTC (Over-the-Counter Drugs)
Compliance Gurus can provide dietary supplement manufacturers with a comprehensive plan to ensure adherence to the regulatory requirements of the Federal Food, Drug and Cosmetic Act, Dietary Supplement and Nonprescription Drug Consumer Protection Act and the Fair Packaging and Labeling Act. We offer guidance on OTC drug monograph conformance, product labeling, packaging, and post-market reporting.
Our services include the generation and review of post-marketing materials, to ensure compliance with FDA and FTC advertising & promotional regulations and guidances.
In addition, we are happy to assist domestic and foreign OTC drug manufacturers distributors with FDA establishment registration and product listing, post-market adverse event planning & reporting, and import/export regulatory requirements.
cGMP (current Good Manufacturing Practices)
The Food, Drug and Cosmetic Act mandates all OTC drug manufacturers, labelers, packagers and holders to comply with good manufacturing practices. Compliance Gurus can update and improve your existing quality management system, in conformance with contemporary, 21 CFR 210-211, regulatory requirements and FDA/ICH guidances. In addition, we are experienced at developing and implementing streamlined, cost-efficient quality plans for new businesses.
OTC drug organizations utilizing electronic systems to create, modify, maintain, archive, retrieve or transmit data records, mandated by the Federal Food, Drug and Cosmetic Act or FDA regulations, must comply with 21 CFR 11. Part 11 also applies to recordkeeping measures, which assign electronic signatures. Compliance Gurus can conduct a Part 11 assessment of your company’s electronic records and signatures, and revise or implement a compliant Part 11 protocol.
Computer System Validation
Compliance Gurus can assist your organization with your computer system validation needs.
We are experts at qualifying infrastructures and validating computerized systems, ranging from small desktop applications, through enterprise-wide applications deployed for global use. Furthermore, our staff has substantial experience validating a variety of GLP, GDP, GCP, and GMP systems and software applications.
The Compliance Gurus team are experts at auditing internal and external regulatory systems, processes and procedures. Whether you have received an FDA 482: Inspection Notice, need to evaluate a foreign supplier or want to perform an FDA mock audit, as part of your inspection readiness plan, we can assist you. We can provide a detailed, comprehensive gap analysis of your company and vendor regulatory requirements, to identify compliance related deficiencies.
Upon discovery, regulatory gaps will be analyzed, from a risk management perspective, and can be addressed through the implementation of a corrective and preventive action plan.
Our auditing services span the entire pharmaceutical product development and quality management lifecycle. We frequently audit 3rd party vendors, including contract manufacturing organizations and contract packaging organizations.
Compliance Gurus can provide employee training to small and large groups. All of our corporate trainers possess advanced degrees and have ample years of experience working in the FDA regulated industry. OTC drug organizations can customize their educational curriculum, by choosing from our comprehensive selection of FDA and over-the-counter drug related content.
Currently, our training topics include: FDA History, The Organization of the FDA, History of OTC Drug Regulation, Good Manufacturing Practices for OTC Drugs, OTC Drug Advertising & Promotion, and Current Trends in OTC Drug Regulation.
FDA Interaction and Remediation
Direct interaction with the FDA is a stressful, apprehensive experience, even when conducted under the best of circumstances. Compliance Gurus is available to alleviate your corporate anxiety, by offering support during this challenging time. If you have received a Form 482: Notice of Inspection, we can prepare you for the audit by providing pre-inspection guidance. In addition, we are available to accompany you, during the inspection, to help mediate any points of contention between the parties.
Compliance Gurus offers comprehensive remediation services for organizations receiving a Form 483 or Warning Letter, after FDA inspection. We can structure and implement an effective remediation plan to efficiently address any compliance deficiencies or violations. If your company has received a Warning Letter, we can author a satisfactory Company Response and devise a corrective action plan, in adherence to the 15-day response timeline.
In addition, our consultants are available to assist corporations with the logistics, which may arise from a voluntary or FDA mandated product recall.