The question it answers
“I have a formula, supplier documents and maybe my CPSR, but my PIF is incomplete, scattered, or I don’t know what is missing.”
€690
7 business days
Prices exclude VAT — VAT treatment depends on the client's country of establishment and professional status. · Turnaround counted from a complete file (brief + documents).
What is checked
- Building and structuring the PIF (Art. 11 of Reg. 1223/2009): product description, formula and specifications, manufacturing method and GMP statement
- Collecting and consistency-checking the documentation: raw materials, claims and evidence, label
- Preparing the data needed for the safety assessment, to hand over to your qualified assessor
- Integrating the CPSR signed by a qualified safety assessor, when available
- List of missing items, ranked by priority
Deliverable
Structured PIF + index of parts + final gap list. If the CPSR is not yet available, the deliverable states explicitly that a CPSR signed by a qualified assessor is still required before the CPNP notification.
Documents to provide
- Quantitative formula and finished product specifications
- Manufacturing method / GMP statement
- Raw material documentation
- Label and claims
- Signed CPSR (if already available)
Follow-up
1 round of written questions included
Not included
- Writing and signing the CPSR (reserved to a qualified safety assessor)
- Acting as Responsible Person
- Laboratory testing (stability, compatibility, challenge test…)
- CPNP notification not included in this service — available separately
Regulatory consulting and documentation preparation — not a certification and not a regulated role. Bridge & Flow does not act as Responsible Person (Reg. 1223/2009), does not write or sign safety assessments (CPSR) and is not a notified body. Where included in the service, Bridge & Flow may prepare and carry out an administrative submission on behalf of the legally responsible entity, subject to the required authorisation, access and information. This does not make Bridge & Flow the Responsible Person, importer, downstream user or other legal duty holder.
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