Product Commercialization & Fda Regulatory Compliance

What is your commercialization strategy for getting your regulated product on the market—and keeping it there?

Product commercialization is the complex process of bringing a new product to market. For pharmaceuticals, medical devices, diagnostics, therapeutics, cannabis product, and beyond the commercialization process can be complex and tricky depending on the product type. The process is multi-faceted and involves several stages, from determining regulatory pathways, ensuring regulatory compliance, confirming product-market fit and positioning, and beyond.

What is your plan for ensuring regulatory compliance? Who will implement it?

The FDA requires product manufacturers and marketers to comply, but does not tell you how. Lawyers charge too much to tell you what the regulations are, but not how to apply rules, regulations and guidelines to get your products on the market, compliantly and impactfully.  Branding experts tell you mistakenly tell you “just don't make medical claims”, but they lack the experience to navigate regulations to get your product compliantly on the market.  With the noisy mixed messaging out there, you need clear, straight-talk from the experienced professionals '68 Partners who have the know-how to navigate local, state, and federal regulations, and translate them into practical regulatory strategies that serve your unique brand and business.

​With decades of real-world experience commercializing FDA regulated products,
'68 Partners knows how to avoid regulatory black ice™, and guide you on a path to sustainable brand equity.  From start-ups to mid-size to multi-national corporations, we design practical commercialization and compliance solutions for any size organization, at any stage of the product life cycle.

What is your market expansion plan? Do you have the right manufacturing and production partners to white label your cannabis product in a new state?

With our deep network of vetted industry professionals and licensed operators, '68 Partners will assist you in finding the right strategic partner or production partner to commercialize your product. The partners in '68 Partners ecosystem are value-aligned and maintain the highest standards of quality and compliance, providing you with the confidence and certainty that your product will be peace of mind as you expand your product line.

Navigating the patchworked cannabis regulatory landscape is daunting. With a trained guide from '68 Partners who can help lead your business through this rough regulatory terrain, the commercialization process can be seamless. Our team will prepare and submission requirements to ensure your product meets all regulations. Uniquely situated at the intersection of cannabis, commercialization, and compliance, our team provides the practical know-how and accurate strategic insights to successfully launch your product on the market—and keep it there.

Service Providers & Stakeholder Consulting

Neque vitae tempus quam pellentesque nec nam. Pretium aenean pharetra magna ac placerat vestibulum lectus mauris. Fermentum et sollicitudin ac orci phasellus egestas tellus rutrum. Volutpat blandit aliquam etiam erat. Ut tortor pretium viverra suspendisse potenti nullam ac tortor. Sit amet nisl suscipit adipiscing bibendum. Tellus in hac habitasse platea. Turpis egestas integer eget aliquet nibh. Morbi non arcu risus quis varius quam quisque id diam. Vitae ultricies leo integer malesuada nunc vel.

Convallis tellus id interdum velit. Enim lobortis scelerisque fermentum dui faucibus in ornare quam. Sed id semper risus in hendrerit gravida. Amet facilisis magna etiam tempor orci eu. Ac feugiat sed lectus vestibulum mattis ullamcorper velit sed ullamcorper. 

Fringilla urna porttitor rhoncus dolor purus non enim praesent elementum. Eu turpis egestas pretium aenean pharetra. Cras ornare arcu dui vivamus arcu felis bibendum ut tristique. Morbi quis commodo odio aenean sed. Pulvinar mattis nunc sed blandit libero volutpat sed. Aliquam sem fringilla ut morbi.

Convallis tellus id interdum velit. Enim lobortis scelerisque fermentum dui faucibus in ornare quam. Sed id semper risus in hendrerit gravida. Amet facilisis magna etiam tempor orci eu. Ac feugiat sed lectus vestibulum mattis ullamcorper velit sed ullamcorper. 

Convallis tellus id interdum velit. Enim lobortis scelerisque fermentum dui faucibus in ornare quam. Sed id semper risus in hendrerit gravida. Amet facilisis magna etiam tempor orci eu. Ac feugiat sed lectus vestibulum mattis ullamcorper velit sed ullamcorper. 

For Clarity, Certainty and Confidence Contact Us Today

© 2019 '68 PARTNERS LLC
ALL RIGHTS RESERVED.
Website by Sheri Tarr in partnership with Green Lane Communications
Photography by Sheri Tarr