Regulatory Consulting And FMEA Analysis

Perhaps no other industries in the world are as tightly regulated as the pharmaceutical, medical device and health care spaces, and for good reason. With the health and wellbeing of people on the line, it is critical that manufacturers do everything possible to comply with the various regulations that apply to them. Even the naming and branding of products must conform to rigid standards all over the world.

This is why so many businesses in these sectors choose Addison Whitney to provide regulatory consulting and failure mode and effects analysis (FMEA) services. Our comprehensive approach explores all angles of branding, including how it must be shaped by considerations for compliance as well as maintain its viability in the global marketplace.

Why Our Services Are Necessary

There’s more to naming a new product in these industries than other markets. In addition to being appealing to consumers, there are many factors that take on added importance because lives are on the line.

For instance, there are strict rules about choosing names that are not too similar to existing copyrights, for fear of confusing different medications. There are substantial disincentives for names that may be seen as exaggerating the efficacy of a particular pharmaceutical or device. Even packaging and labeling must be designed within certain parameters to prevent confusion or misrepresentation.

This is why it is crucial to have us by your side as your pharmaceutical and medical devices consultants. Our expertise in brand development means our pharma and medical device regulatory consulting solutions can help you develop naming and branding that remains within the confines of these rules, so you don’t have to worry about these concerns holding up the release of your new product line.

We also have the knowledge to provide FMEA analysis that can guide you toward the most effective brands for you. This includes ensuring the naming, imagery and other marketing features translate to other cultures and languages and that they tell your story as effectively as possible. Our range of capabilities include:

  • Regulatory name submission strategy & documents
  • Name safety research / gap analysis
  • Canada name safety research & FMEA
  • Consults & rebuttals
  • USAN/INN / stem & class naming
  • Nonproprietary (USAN/INN) name evaluations research
  • Non-proprietary applications / submissions
  • Product labeling, packaging & trade dress research
  • Regulatory / safety review of container, carton, labels & packaging 

Why Choose Addison Whitney?

We stand apart from other regulatory consulting companies because we do more than help you with branding for a single product or line. In addition to guiding numerous enterprises through the process of developing an identity for individual products, we have also helped organizations create a comprehensive brand that tells their stories more effectively.

To learn more about our medical device regulatory consulting services or anything else we can do for you, get in touch with us today.