Giving a Presentation

PRODUCT DEVELOPMENT AND REGULATORY AFFAIRS/SUBMISSION SUPPORT

Product development and commercial teams often don't recognize the value a clear, defined, actionable regulatory strategy can provide in not only reducing time to market, but also achieving broader indications and greater flexibility in terms of marketing and sales activities.

JENLO Compliance works closely with clients to be more than an administrative arm of the project. We will work closely with you to develop a plan for navigating the regulatory process whether it is a prescription or OTC drug, biological product, medical device, combination product, controlled substance, veterinary drug or device or food/dietary supplement. 

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REGULATORY AFFAIRS SUPPORT

APPLICATION SUPPORT

  • Application Support for IND, DMF, NDA, ANDA, 505(b), BLAs

  • Requirements for investigational products (i.e. INDs and IDEs)

  • Orphan Products (Orphan Drugs, Humanitarian Devices (HDE), Minor Use Drugs)

  • PMA and 510(k) submissions including De Novo petitions

  • Preparation for and participation in Pre-Submissions Meetings and FDA Advisory Committee/Advisory Panel meetings

  • Label development strategy and review

  • EMA strategy and submissions support

  • eCTD publishing and submission support for FDA, EMA and Health Canada

  • Pre-Approval Inspection (PAI) Strategy and Support

POST MARKET SUPPORT