NOTICE: We can assist your cosmetics company in achieving FDA compliance through our expertise in pharmaceutical consulting and regulatory affairs.

Gap regulatory consulting

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Compliance, Registrations, Audits & Training

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Gap regulatory consulting

Gap regulatory consultingGap regulatory consultingGap regulatory consulting

Compliance, Registrations, Audits & Training

  • Home
  • About Us
  • Services
  • Contact Us

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

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.

FDA, DEA, & States Compliant Standard Operating Procedures

FDA, DEA, & States Compliant Standard Operating Procedures

FDA, DEA, & States Compliant Standard Operating Procedures

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.

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, 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.

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

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.

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 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.

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 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.

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