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

Initial company registration and label code application
Annual establishment registration
Registration of product NDC
Coordination of Structured Product Labeling
Ongoing regulatory intelligence

FDA, DEA, & States Compliant Standard Operating Procedures

FDA, DEA, & States Compliant Standard Operating Procedures

FDA, DEA, & States Compliant Standard Operating Procedures

Turn-key operating manual for WDD, 3PL, Virtual, Repackager
Provides 3rd-party unbiased internal and vendor Quality Audits in accordance with FDA 7356.002
Assits with FDA 483 Response and CAPA follow through

Vast Network of Vendors with Decades of Experience

FDA, DEA, & States Compliant Standard Operating Procedures

Inspection of Company Printed Materials; Quality Agreement, Sales Material, Labels, Reporting

Producers of tablets, capsule, powder, cream, gel, and liquid products
Controlled product warehousing and other specialty logistics
Producers of components, containers, labels, etc.

Inspection of Company Printed Materials; Quality Agreement, Sales Material, Labels, Reporting

Inspection of Company Printed Materials; Quality Agreement, Sales Material, Labels, Reporting

Inspection of Company Printed Materials; Quality Agreement, Sales Material, Labels, Reporting

Compliance with 21 CFR 203
Provides advisement of label and packaging design
Advisement of label flow between trade partners
Review of marketing materials

Executive Edit & Training of Company Policies and Procedures in accordance with cGMP

Inspection of Company Printed Materials; Quality Agreement, Sales Material, Labels, Reporting

Advise & Correspond with DEA on Controlled Substance Marketing, Warehousing, Distribution

Compliance with 21 CFR 211
Provides training on HIPAA, PDMA, cGMP, SOP compliance and maintains training records
Provides periodic internal audits and SOP revision oversight

Advise & Correspond with DEA on Controlled Substance Marketing, Warehousing, Distribution

Inspection of Company Printed Materials; Quality Agreement, Sales Material, Labels, Reporting

Advise & Correspond with DEA on Controlled Substance Marketing, Warehousing, Distribution

Compliance with 21 CFR 1300
ARCOS reporting and monthly CS reporting for state agencies
Ensures all internal SOPs are current, managed properly, and trained thoroughly