Never Too Early To Plan for the FDA

Plan your work and work your plan. In the case of the US Food and Drug Administration, there is not a truer saying. The catch is to start early, almost as soon as the decision is made to commercialize a discovery.

“Typically a company has a fabulous idea and a little bit of money coming in,” said Russ King, managing partner of MethodSense, Inc. “The temptation is to pump every cent into the development of the product and not allocate funds to properly plan their regulatory strategy. That in our experience is a shortcut that will typically generate unnecessary costs in the long run.”

Russ’ experience is based on 23 years in life science companies working in medical devices, healthcare and professional services enterprises through which he’s acquired expertise in compliance operations, business development, customer support and strategic alliances. 

MethodSense is also built on the experience of Rita King, managing partner of MethodSense. Rita spent 10 years working at UL (Underwriters Laboratories), a global product safety testing and certification organization, where she worked with US, European, Canadian and Japanese regulations across multiple product categories.  She also has 22 years of experience as a professional auditor and as a regulatory affairs expert. 

Through their combined experience, the Kings have identified the common pitfalls that companies, especially young ones, should avoid to set down a smoother, faster and potentially less expensive road through the FDA.

Click here to read the entire Interview.

About MethodSense

MethodSense is a Life Science service company adding value to pharmaceutical, medical device and contract service companies with the convergence of Quality, Regulatory and Technology Expertise. Where technology impacts your company, either as a critical business solution or part of your product portfolio, MethodSense can contribute to your success. MethodSense delivers FDA submission support, compliance strategies, quality system development, process and validation strategies and execution, vendor and internal audits, software development methodology optimization, software design control evaluations, risk remediation and GxP, 21 CFR Part 11, ISO, HIPAA, CMM expertise.