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.
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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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Scroll down for specific services and support.
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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
Life Cycle management and post approval change strategies (see also Field Corrective Actions)
GxP support activities
Risk Evaluation and Mitigation Strategies (REMS)
Post-Market reporting and adverse drug experience (PADE) (see also Complaint Handling/Adverse Event Reporting)
Change Control and regulatory submissions assessment