You create
the cosmetics.
We handle
the regulatory.
Add regulatory expertise to your manufacturing offer. Give your clients a clear path from formulation to product documentation, with BiSafe as your specialist partner.
COSMETIC PRODUCT
Safety.
Documented.
PRODUCT SAFETY REPORT
formula.SKINCARE / 100 ml
One manufacturing partner.
A more complete service.
Your clients come to you to turn an idea into a product. Regulatory documentation can be part of that same experience. BiSafe supports the technical work, while you choose how the service fits into your client relationship.
The detail behind
every launch.
Choose support for an individual product
or build a recurring working relationship.
CPSR preparation
Safety assessment and preparation of the Cosmetic Product Safety Report, based on the formulation, ingredient data, exposure and available product evidence.
PIF compilation
Organising the Product Information File: product description, safety documentation, manufacturing information and supporting evidence for product claims.
CPNP notification
Support with product information and submission to the Cosmetic Products Notification Portal for the agreed EU market scope.
Labels, claims & testing
Review of ingredient lists, label information and claims, with identification and coordination of testing needs for the individual product.
Scope, deliverables and any testing requirements are agreed for each project. Documentation support does not itself appoint BiSafe as the Responsible Person.
Your client relationship.
Your choice of partnership.
BiSafe as your subcontractor
You remain the client’s main point of contact and include the agreed regulatory services in your offer. BiSafe carries out the specialist work as your subcontractor.
- Agreed communication and confidentiality
- Defined inputs, deliverables and responsibilities
- Project pricing or recurring cooperation
BiSafe works directly
with your client
You introduce your client to BiSafe for a separate regulatory engagement. We coordinate the required information with you and your client, within an agreed scope.
- A separate proposal for the regulatory work
- Direct discussion of documentation requirements
- Coordination with your development team
Start with one product.
Build from there.
A first project lets us establish a working
process before expanding cooperation.
Share the brief
Tell us what you manufacture, your target markets and where you need regulatory support.
Agree the scope
We review the available information, identify gaps and define the deliverables, price and timing.
Prepare & coordinate
We carry out the agreed work and coordinate questions, supporting documents and any testing needs.
Support the next step
Discuss updates, new variants and further products as your client portfolio develops.
BiSafe. Regulatory expertise
for your next chapter.
Led by dr. Mark Stanojević, BiSafe d.o.o. supports businesses with chemical and cosmetic regulatory work. This partnership brings our cosmetic documentation services into your manufacturing workflow.
Before we begin.
Can we start with a single product?+
Yes. A first product is a practical way to define the workflow, confirm the required inputs and evaluate the cooperation before discussing a broader partnership.
What information is needed for a proposal?+
Start with the product type, target markets, number of products or variants, formula availability and the services you need. We then agree how to exchange formulation and technical documentation securely.
Can the same file be used for multiple brands or variants?+
The scope depends on differences in formulation, intended use, packaging, claims and product identity. We review the proposed range before confirming which work can be shared and which requires separate assessment or updates.
How are pricing and timelines agreed?+
We prepare a proposal based on the product, available documentation, required work and any testing needs. Recurring collaboration and product families can be discussed individually.
Can you help after the initial project?+
We can agree support for changes to formulas, labels, claims and product information, as well as additional products. The scope and responsibilities are defined for the relevant work.
Your next service
could start with
a conversation.
Tell us about your manufacturing business and the regulatory support your clients need.
dr. Mark Stanojević
BiSafe d.o.o.
Product types · Target markets
Number of products · Support needed
Book a 20-minute introductory call. Prefer email? Contact info@bisafe.si. Joining details will follow by email.
