Compliance Assessments

Compliance Gurus Incorporated (CGI) will proficiently assess your company’s level of adherence to FDA requirements. Our experienced team will evaluate your procedures, processes and records to generate a detailed Compliance Assessment Report, which identifies your company’s compliance strengths and weaknesses. In addition, the report will provide sound recommendations and cost-effective solutions to expediently address any compliance deficiencies.

Auditing

Our professionals are adept at conducting both internal and external audits. Our independent assessment of your company’s in-house practices and procedures will give your company the advantage of reinforcing sound regulatory initiatives, while promptly addressing any compliance oversights. In addition, we audit third-party subsidiaries, such as external vendors, manufacturers, distributors and storage facilities, whose mandatory compliance is essential to your business.

Computer System Validation

We have experience in validating a vast array of GCP, GLP and GMP systems. In addition, we assist our clients in meeting the requirements mandated by the Code of Federal Regulations, especially those prescribed in 21 C.F.R. Part 11.  Our skilled team will gather your user requirements and assess your system, to ensure that it is designed and tested to operate as intended. For those whom are unfamiliar with computer system requirements and/or are new to operating in a regulated space, we will create a validation project plan that will guide you through every step of the regulatory process; from designing User Requirement Specifications, through authoring Validation Summary Reports, and into production.

Quality System Implementation

If your company aspires to enter or expand into the medical device industry, our professionals can help you achieve your goal.  We specialize in implementing Quality Systems that adhere to 21 C.F.R. Part 820 requirements. Whether you are a medical device manufacturer or a vendor supporting the medical device industry, our team will guide you through the process of establishing a comprehensive quality system. Beginning with the establishment of prerequisite Current Good Manufacturing Practices (CGMPs), our team will diligently ensure that your new system meets all federal requirements, in a time and cost efficient manner. In addition, we provide long-term auditing support for those medical device manufacturers, whom are legally required to audit their vendors on a periodic basis.

Remedial Compliance Consulting

If your company has been cited for regulatory violations or is experiencing frequent deviations or CAPAs, we can provide a compliance solution for you.  Our professionals have experience in devising remedial plans in response to FDA FORM 483 Citations, FDA Warning Letters and FDA Untitled Letters. Regardless of your situation, our team will expediently assist your organization in resolving FDA violations by advising and implementing corrective actions.

Training

At Compliance Gurus, we not only believe in acquiring knowledge, but believe in sharing it as well. We offer onsite training for FDA regulatory topics, such as GCP, GLP, GMP, auditing, computer systems validation and general FDA awareness. We take the time to fully explain not only the regulations themselves, but the justification and importance of complying with them. Our customized training sessions allow for one-on-one individualized instruction or training seminars and workshops, to accommodate larger groups. Whether you need training for a new employee unfamiliar with working in a regulated space, or just want to refresh and enhance the knowledge of your employees, we can create a training program for you.

U.S. Regulatory Assistance for Foreign Companies

If your company is based outside of the United States, but seeks access to the U.S. biotechnology, medical device, food, cosmetic, or pharmaceutical industry, Compliance Gurus can help. Our professionals frequently assist internationally based companies gain access to the U.S. marketplace by developing a comprehensive compliance strategy plan. The plan begins with a review and analysis of your company’s current policies and procedures, to determine if they are compliant with U.S. regulations. If not, our team will create a systematic compliance strategy that will guide you through the U.S. regulatory process, implement mandatory protocols and processes, assist your completion of necessary paperwork, and ultimately achieve FDA approval. Our goal is to gain your company entrance into the U.S. business arena in the most expedient and cost-effective manner.