Compliance, Registrations, Audits & Training
Liaison for Business and Government
FDA Registration: Companies & Product Annual Listing
FDA, DEA, & States Compliant Standard Operating Procedures
FDA, DEA, & States Compliant Standard Operating Procedures
We help companies manage FDA registration from start to finish, including initial registration, labeler code application, annual renewals, and product listing with NDC assignment. We also handle Structured Product Labeling (SPL) coordination and provide ongoing guidance to keep your business compliant.
FDA, DEA, & States Compliant Standard Operating Procedures
FDA, DEA, & States Compliant Standard Operating Procedures
FDA, DEA, & States Compliant Standard Operating Procedures
We develop and support comprehensive standard operating procedures (SOPs) for WDD, 3PL, virtual, and repackager operations. Our services include independent internal and vendor quality audits aligned with FDA guidelines, as well as support for FDA 483 responses and CAPA implementation. We provide practical regulatory guidance to help ensure your operations remain compliant and audit-ready.
Vendor Network & Compliance Support
FDA, DEA, & States Compliant Standard Operating Procedures
Review of Printed Materials & Compliance Documentation
We connect clients with a trusted network of experienced vendors supporting the production of tablets, capsules, powders, creams, gels, and liquid products. Our services also include guidance on compliant warehousing and specialty logistics, along with regulatory support to help ensure products and processes meet industry standards. We provide practical insight to help clients navigate complex supply chain and compliance requirements with confidence.
Review of Printed Materials & Compliance Documentation
Review of Printed Materials & Compliance Documentation
Review of Printed Materials & Compliance Documentation
We provide thorough review of company materials to ensure alignment with 21 CFR 203 and other regulatory requirements. This includes labels, packaging, quality agreements, sales and marketing materials, and required reporting documentation. We also support coordination of labeling between trade partners, helping ensure accuracy, consistency, and compliance across all materials.
Policy Review, Training & cGMP Compliance
Review of Printed Materials & Compliance Documentation
DEA Compliance & Controlled Substance Support
We offer comprehensive review and training of company policies and procedures in accordance with 21 CFR 211 and cGMP standards. Our services include training on HIPAA, PDMA, and SOP compliance, as well as support for maintaining accurate training records. We provide ongoing oversight and updates to ensure continued alignment with evolving regulatory requirements.
DEA Compliance & Controlled Substance Support
Review of Printed Materials & Compliance Documentation
DEA Compliance & Controlled Substance Support
We offer compliance consulting and direct coordination with the DEA for companies involved in the marketing, warehousing, and distribution of controlled substances. Our services include adherence to 21 CFR 1300, ARCOS reporting, and state-required controlled substance reporting. We also support SOP management and training to ensure ongoing compliance and operational readiness.