Compliance Specialists, L.L.C. provides a wide range of consulting services to support Pharmaceutical and Medical Device Companies. Compliance Specialists, L.L.C will provide your company with consulting services that are personal, efficient, and suitable to your level of resources.
Regulatory compliance solutions offered by CSLLC focus on identifying root causes. I help you implement processes that achieve consistent and repeatable compliance results that are applicable to any regulation, guidance, or operating standard.
FDA compliance and a sound quality system, along with a supportive infrastructure, are strategic keys to the success of a company operating in a highly regulated environment. With so much at stake, companies need sound advice from an experienced and professional FDA Consultant you can trust - an FDA Consultant who helps clients minimize risk and target their resources to the most important compliance issues. Additionally, I assure that my compliance solutions align with the company’s business plan so that quality initiatives are fully integrated into the company’s business strategy.
Recently the FDA has established the requirement that NDC Code requests, establishment registration submission, and drug listing submission be made electronically. This process is time consuming and not user friendly. CSLLC can make submissions for you or assist with the completion of submission forms and/or trouble shooting errors returned from the validation processor from the FDA Gateway.
I look forward to hearing from you to discuss your needs and the services that Compliance Specialists, L.L.C. can offer your company.