Pre-market approval required
For many products and uses, pre-market approval by authorities is required. Such approval will only be granted on basis of a dossier that is prepared according to the pertinent law and regulations. Moreover, the data presented in the dossier should should lead to the conclusion that consumption of the product as proposed by the applicant is safe.
Interaction with authorities
After a dossier is submitted, it may be checked for completeness and will subsequently be evaluated by health authorities. This process inevitably takes time and is never fully predictable. Even if you have done your best, questions are often asked about a dossier. Sometimes, a clarification or explanation can be given quickly. Sometimes, data gaps are identified, or the conclusion that a product is safe can be challenged by health authorities. Then, further involvement of experts, further testing, adaptating consumer information or proposing post-launch monitoring may be considered.
A guarantee of final acceptance cannot be given. Still, even if all innovations are different, previous experience with registrations helps to avoid unnecessary delays and complications.
No pre-market approval required
For certain products and uses, no pre-market approval is required. If so, a safety dossier may still be needed. It can be prepared for review by an independent, non-governmental expert panel, such as a panel convocated to obtain GRAS status in the USA. A safety dossier can also be used, for example, for ad hoc inspection at request of authorities, or to inform interested parties, like investors or customers.
Considering the product, its use, the pertaining regulations as well as the marketing and communication strategy, it may be decided if, when and how results of tests should be submitted for publication in a peer-reviewed scientific journal.
Services provided in the registration phase may include, for instance, one or more of the following:
- preparing a dossier for registration
- consulting with authorities and representing the manufacturer
- submitting of a dossier for registration
- consulting with external experts in order to address specific issues
- handling questions received from authorities
- monitoring the preparation of manuscripts for publication