Outsourced Regulatory Affairs (ORA)

Regulatory Strategy – FDA Submissions

Signs You Need Outsourced Regulatory Affairs

Your company has developed a great product, but will you be able to handle all elements of the submission, including pre-clinical, clinical, pharmacokinetics, CMC, and drug safety yourself? Without years of experience and a large regulatory affairs staff, the answer is probably no. The Weinberg Group can help you effectively tackle these tasks with our Outsourced Regulatory Affairs (ORA) service, which allows you access to professionals with broad experience in FDA regulatory consulting. Our experts will guide you through each step necessary to successfully complete an FDA submission.

Our In-house FDA Consulting Team Will Help You

  • Create customized FDA regulatory/development strategies.
  • Conduct the appropriate literature research, especially important for 505(b)(2) NDAs.
  • Prepare for and attend key meetings, like pre-IND.
  • Write all submission documents.
  • Act as a U.S. Agent for non-U.S. companies.
  • Respond to FDA questions during the approval process.
  • Navigate the Electronic Common Technical Document (eCTD) process.
  • Maintain regulatory files.
  • File annual reports, adverse reactions, and ongoing CMC updates.
  • Manage Good Manufacturing Practice (GMP) and clinical site audits.

We work with your product development team to assure that the right studies are done, in the proper order. ORA provides you with a dedicated project manager who will act as a member of your in-house FDA regulatory affairs team, taking on the burden of all regulatory tasks and delegating responsibilities to our expert team. No more need to manage a host of external consultants. This project manager will develop project milestones, think ahead to minimize potential FDA regulatory hurdles, bring in other experts as needed, offer ad hoc advice, and provide budget control and certainty.