Services

 Turn-key, or project-based, support for development and commercialization of medical, cosmetic and recreational herbal inhalation products, edibles and topicals.

Helping start-ups and medium sized businesses deliver viable product roadmaps, prototypes, proof of concept studies and commercial solutions.

Rapid, early stage P.O.C., enabling strategic business planning through goal driven iterative product development services,.

Specific considerations given to quality, safety, toxicology, analytical sciences, product COGS, ingredient sourcing, manufacturability and more.  

Project-based services to accelerate your product development goals at low risk.  

Ensure that your product meets regulatory requirements in your target market, from early stage concepts, continuing through to commercial products.

We will provide an initial risk assessment for your product or product concept, and corrective actions along the development life-cycle to meet regulatory requirements.

What makes us different?

Thirty (30) years of hands on experience in pharma API, pharma final product, cosmetic, tobacco, cannabis and naturals product development and manufacturing.

  - FDA  submissions 

- Product regulatory requirements

- QMS and quality systems

- Documentation & Controls

- Manufacturing Controls

- Analytical Laboratory Services

- Device and Vapor Characterization, 

- Electrical safety standards

- Validation & Stability, 

- Toxicology, 

- Human and Animal Studies 

- China operations including parts manufacture, vendor management and assembly controls.

- Materials safety assessments

 We will:

Reduced product development time by rapid iterative R&D development cycles with fast analytical sciences feedback between iterations.

Timeline, quality and budget optimization.

Engagement of key departmental stakeholders from:

Brand, Business Development, R&D, engineering, regulatory, product safety, analytical labs, QA, QC, clinical studies, manufacturing and legal. 

Early integration of quality management in device specifications, performance characterization, validation, verification, stability and device history file documentation.

 Rapid R&D laboratory services for the chemical, physical and electrical characterization of materials, components and products.

Lower COGS, improve prototype manufacturing consistency, continuously evaluate safety and tox risks to lower product development risk.