Do I need an Investigational New Drug (IND) Application to use my novel drug or biologic product?

Is my product a medical device? How would FDA regulate my medical device? What are the pathways to marketing my medical device?

These are the types of questions that our team of regulatory professionals and scientists are here to answer. We can help you avoid many of the regulatory roadblocks on your product’s journey from early-stage development to commercialization.

Many members of our Regulatory Affairs team have scientific backgrounds and experience interacting with FDA. We are capable of assisting academic spin-offs, new product developers, established manufacturers and retailers with all of their regulatory needs.

Scalable Regulatory Solutions

Strategic and technical guidance

  • FDA submissions and review process
  • Postmarket requirements (reporting, safety & quality systems)
  • Regulatory risk assessment related to potential mergers and acquisitions
  • Pre-clinical and clinical design

Regulatory submissions

  • Drugs/Biologics: INTERACT, Pre-IND, IND, NDA, BLA
  • Medical devices: Pre-Subs, IDE, HDE, 510(k), De Novo, PMA
  • Preparation of electronic submissions (eCTD, eCopy, NeeS)
  • Submission using FDA Electronic Submissions Gateway (ESG)
  • Advisory committee analysis

Preclinical testing and GMP manufacturing support

  • Development and execution support for preclinical studies or GMP manufacturing
  • Review of Standard Operating Procedures

Inspection support and compliance assistance

  • Analysis of FDA communications and recommend responses
  • Implement responses to FDA audit observations

Areas of Experience

  • Food and dietary supplements
  • Cosmetics
  • Drugs
  • Biologics
  • Vaccines
  • Animal feed and drugs
  • Medical devices and radiation-emitting products
  • Combination products