Compliance, Registrations, Audits & Training
Compliance, Registrations, Audits & Training
Our compliance consulting services include initial company registration and label code application, annual establishment registration, and registration of product NDC. We also offer FDA registration services, ensuring the coordination of Structured Product Labeling, along with ongoing regulatory intelligence to keep you informed.
Our turn-key operating manual for WDD, 3PL, Virtual, and Repackager services includes comprehensive compliance consulting. We provide 3rd-party unbiased internal and vendor Quality Audits that align with FDA 7356.002 regulations. Additionally, we assist with FDA registration services, including support for FDA 483 Response and effective CAPA follow-through, ensuring you benefit from our regulatory intelligence.
Producers of tablets, capsules, powders, creams, gels, and liquid products benefit from compliance consulting to ensure they meet industry standards. We offer controlled product warehousing and specialty logistics, alongside FDA registration services to streamline the process. Additionally, we cater to producers of components, containers, labels, and more, providing essential regulatory intelligence to navigate the complex landscape.
Our compliance consulting services ensure adherence to 21 CFR 203 while providing expert advisement on label and packaging design. We facilitate the flow of labeling between trade partners and offer comprehensive review of marketing materials, all supported by our FDA registration services and regulatory intelligence.
Compliance with 21 CFR 211 is essential for any organization. Our compliance consulting services provide comprehensive training on HIPAA, PDMA, cGMP, and SOP compliance while maintaining thorough training records. Additionally, we offer FDA registration services that include periodic internal audits and SOP revision oversight, ensuring that your organization stays aligned with the latest regulatory intelligence.
Compliance consulting with 21 CFR 1300, along with ARCOS reporting and monthly CS reporting for state agencies, ensures that all internal SOPs are up-to-date, managed effectively, and trained thoroughly. Our FDA registration services and regulatory intelligence further support this compliance framework.