Services

   Your success is our first priority!  

   We are focused in four major areas to assist you:  chemistry, manufacturing, and controls
   (CMC); intellectual property; technical writing; and, portfolio review.  If we do not offer the
   services to assist you, please contact us and we will do our best to help you find an
   appropriate source. 

 

Our focus on CMC revolves around helping you with formulation development, analytical method development/validation, device development, and manufacturing.  Our experience with formulations includes solutions and suspensions; non-aqueous and aqueous systems; and, pressurized and non-pressurized systems.  Due to the nature of the products, unique analytical and product testing methods had to be developed and validated.  Similarly, novel devices were developed to meet product and legal specifications.  We have domestic and international technology transfer experience.  If needed, we can help you screen and select contract research organizations to meet your CMC needs.

 

Our intellectual property focus centers on the technical assessment of your current and future patents and applications.  This assessment can include determining the relative scientific strength of your patents compared to others in your field.  Based on our experience we could recommend ways to scientifically strengthen your position.  We can also help you select outside patent counsel to meet your needs.

 

Our focus on technical writing includes helping you write internal documents, as well as drafting and reviewing regulatory documents.  We have experience writing standard operating procedures, scientific reports based on collected data, and white papers.  We also have experience writing successful CMC documents for regulatory submissions including briefing documents, INDs, NDAs, and annual updates.  We can also help you select outside contractors to provide regulatory submission support.

 

Our focus on portfolio review is a high level activity designed to assess the strategic positioning of your product portfolio and/or product pipeline.  We offer an unbiased outsiders opinion regarding the current strategy and offer alternatives, if applicable.

 

In addition to our services, we have contacts that could help you with:

·         Technology validating studies

·         Pre-clinical studies

·         Clinical studies

·         Taste assessment and optimization

·         Child resistant packaging – design, development, manufacturing, and testing

·         Manufacturing – US and international

·         Regulatory submissions