let us help make it easy for you.
No one likes paperwork, and compliance in the vaping world is a constantly moving target with regulations and guidelines changing on a near daily basis. We make it easy for our clients with our ‘Rapid Adoption’ approach to the ever changing regulatory landscape. Our approach is built on a team of proven professionals drawn from the Military, Medical, Chemical, Pharmaceutical and Nutraceutical fields, all dedicated to keeping up, and making it easy for our clients.
From state level tax reporting, business registrations, licensing, and onsite certification requirements, our team is here to help you meet the specific requirements of your state.
Our 600 person Law firm is based in Washington, DC and specializes in FDA compliance across industries. They make sure we stay up to date with all Federal Regulations, Submission Requirements, and New Registrations as they emerge.
With access to Europe and Asia, our specially tailered products and product registrations make sure our international retailers are protected and insurable.
When it comes to protecting your business, protecting your customers, and making payroll every month, you deserve the peace of mind that comes with documents you know you can show a judge or inspector. We call these “Admissible Documents” because they meet the requirements of admissibility for: The Judicial System, Law Enforcement, Federal Regulations, Customs, and Insurance Providers.
We understand that professionally authored “Admissible and Accredited Documents” are a major key to sleeping well at night knowing your compliant with the laws of the land.
No-one actually likes paperwork, and in the vaping world, there is a ton of it. We’re here to make it simple, professional, and easy for you. Whether it be “Certificates of Authenticity” or “Certificates of Conformity” or “Batch Level Trace-ability” or “Customs Forms” or “SDS Sheets” or anything else you may need for your specific state or region, our military trained Logistics, Supply and Compliance director is just a phone call away, dedicated to following the law and making your life easier.
CROSS INDUSTRIAL COMPLIANCE
There is a dangerous myth in the Vaping industry that suggests: “The FDA is the only agency we have to comply with.” That’s a myth that has cost many business owners hundreds of thousands in fines. The truth is: All laws, all agencies which govern manufacturing and commerce, also govern vaping. From Environmental Waste to Occupational Health and Safety, to Customs, and Materials Transport, compliance is woven into every aspect of our corporate DNA. Cross Industrial Compliance means that we seek to comply with the highest standards of manufacturing excellence across industries. The Three Rules:
Documentation is only as good as the credentials of who provides it.
2. Audit Trace
Third Party audits add weight and accountability to documentation.
Documentation must be Correct, Current, Complete, and Relevant.
HERE ARE A FEW OF OUR CREDENTIALS:
COMPLIANCE PROGRAM FEATURES
CFR 16 1700.20
We provide GCC’s for CFR Title 16 Part 1700.20 Child Resistant Packaging for all our products.
We maintain batch level trace-ability down to the molecules included in every batch we make.
We maintain up-to-date Globally Harmonized SDS sheets for our products.
We maintain retained samples for 100% of our batches in a climate controlled center for 3 years.
We’ve built our facility and SOP’s to exacting Nutracuetical and Cosmetic standards
Onsite High Performance Liquid Chromatography Capabilities to meet COA requirements.
We source our raw materials from TPMF (Tobacco Product Master File) compliant manufacturers.
CFR 21 § 110
We maintain CFR 21 § 110 shipping, storage and outer packaging (shipping boxes) compliance.
Certificates of Analysis
Random sampling and third party analysis is conducted ongoing to ensure product conformity.
Annual Independent Audits
Our facility and processes are independently audited twice annually.
Everything we do is traceable and prescribed by a comprehensive set of ISO audited SOP’s.
ANSI and OSHA
We adhere to and comply with ANSI and OSHA guidelines for the safety of our staff and customers.
Our Hazard Analysis and Critical Control Point protocols insure that we are always improving.
DEQ / EPA
We strictly adhere to federal environmental protection standards for waste disposal.
Our 11,000 square foot facility maintains three HEPA controlled clean rooms.
We use United Kingdom Accreditation Service auditors for international inspections.
We’ve chosen to follow a PMTA application for far reaching future compliance.
We use ANAB auditors to insure calibration of our equipment and processes are correct.
A WINNING EQUATION
Having a CEO who is a Professional Statistical Process Control Engineer with over 20 years experience in regulatory and legislative politics gives us a major advantage in understanding and complying with the changing regulatory climate. It isn’t easy, it isn’t straightforward, but we hope our clients and customers can rest easier, more confidently knowing that we are committed compliance professionals working our little butts off over here to keep up with the rapidly changing regulatory environment.
From people’s choice awards to the cover of Vapor Digest our 300k members agree that our 7 brands make sure we have a world class product available for everyone.
The only way to get great products in the hands of customers, is to make sure that they are legally, and ethically prepared at the highest standards on the planet.
Morgan is genuinely one of the nicest people I’ve ever met, that’s why we put her in charge of making sure our customers are cared for in everything we do.
Pulling Your Hair Out over Compliance?
Let us do the heavy lifting for you, we understand, and we try hard.