Adverse Reaction Reporting on the part of product licence holder is mandatory in Canada for both natural health products (NHPs) and drugs. In the United States, dietary supplement manufacturers, packers, and distributors are required to comply with adverse even reporting and record keeping requirements.  Many companies do not have the in-house expertise to fulfill this obligation. dicentra has both the scientific expertise and the regulatory expertise.

Our services in this area include:

• Adverse reaction evaluation and classification
• Preparation of adverse reaction case reports
• Preparation of adverse reaction annual summary reports for Health Canada and the Marketed Health Products Directorate (MHPD)
• Guidance on how, when, and where to submit serious adverse event reports
• Record maintance for serious and non-serious adverse events
• Preparation and submission of FDA Form 3500A

You can minimize your legal risks by having dicentra handle your adverse reaction reporting.