Center for Regulatory Guidance

87 percent of the names we recommend are approved by global regulatory bodies. Just for perspective, the industry average approval rating for these regulatory bodies is about 62 percent. You do the math.

The Center for Regulatory Guidance is dedicated to helping our clients navigate the complicated pharmaceutical regulatory landscape and gain regulatory approval for their asset.

Depending on where you are in clinical development and when (and where) you plan to launch your drug there are different regulatory factors and milestones you need to know. Missing any of these milestones can set you back months, or even years, and cost you millions of dollars in getting your drug to market.

By partnering with Addison Whitney, we become an extension of your team. Not only will we make you aware of key milestones, but we will work with your team to develop the best regulatory submission strategy to move through each step with confidence and ultimately gain global name approval.

Services

  • Regulatory strategy
  • Name safety reports
  • Submission documents/packages
  • Medical panel reviews and evaluation
  • Name safety research
  • Failure mode and effects analysis (FMEA)
  • Trademark prescreening
  • Phonetic and Orthographic Computer Analysis (POCA)
  • Packaging, trade dress and product labeling research
  • USAN/INN/Stem and class naming