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
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Overview

The Womble Bond Dickinson FDA Regulatory Affairs Team has decades of experience supporting clients in the pharmaceutical, medical device, tobacco, and food/dietary supplement industries. We offer scalable solutions to address the full range of issues around FDA-regulated products. 

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Key Contacts

Our Regulatory Affairs Attorneys

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What We Do

Scalable Regulatory Solutions


Our team is comprised of first-rate scientists and lawyers with the training and experience to provide strategic regulatory guidance and scientific research and consulting services..

Areas of Experience

  • Food and dietary supplements
  • Drugs
  • Tobacco products
  • Medical devices

Strategic Guidance

  • FDA submission strategy and planning
  • Agency rulemaking comments
  • Comprehensive literature reviews
  • Diligence assessments for M&As

Regulatory Submissions

  • Drugs: Pre-IND, IND, NDA
  • Medical devices: Pre-Subs, HDE, 510(k), De Novo, PMA
  • Preparation of agency-compliant electronic submissions
  • Advisory committee meetings

Research and Consulting

  • Data management and analytics consulting, statistical programming, and research design
  • Clinical study design protocols and study reports
  • Medical writing services: scientific manuscripts and study reports
  • Population modeling, surveys, and behavioral research
  • Post-market surveillance programs: design, implementation, reporting, safety and risk assessments

Inspection Support and Enforcement Actions

  • Analysis of FDA communications, warning letters, and response recommendations
  • Responses to FDA audits and inspections
     
Need legal advice and guidance in regulatory affairs?
Our team is able to help provide solutions to you and your organization. Browse through our lawyers and professional staff to find the right attorney near you.
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WBD Advance operates as captive service providers within the firm, utilizing lawyer and staff resources to meet an identified legal or business need in the greater marketplace.

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