Confidentiality from the first contact
A non-disclosure agreement (NDA) before any exchange of product data.
Scientific rigor, confidentiality and direct communication.
What happens after you contact us
Every project is scoped individually. This is the path from your first message to a written proposal.
Start with a short message- 1
You send a short message.
Tell us about the product and the regulatory goal. No confidential data is needed at this stage.
- You send
- Your name and email, then your area of activity and a short message
- You receive
- An on-screen confirmation with these steps
- 2
We reply to schedule.
We read your request and come back with times for a diagnostic meeting.
- You send
- Your preferred time
- You receive
- The meeting invitation
- 3
NDA first, if you need it.
If you want to discuss product data in the first meeting, we sign a mutual NDA before it. Otherwise the first conversation stays non-confidential.
- You send
- Your NDA request
- You receive
- A mutual NDA to sign
- 4
Diagnostic meeting, at no cost.
A video meeting to understand your program, target agency, existing data and timeline.
- You send
- Information about the program
- You receive
- A first reading: whether the case fits, what kind of project makes sense and which data are needed to scope it
- 5
Data for scoping, under NDA.
If needed, you share the documents that let us size the work.
- You send
- Existing documents and data
- You receive
- Confirmation of receipt and, if anything is missing, a list of what is missing
- 6
A written proposal.
Scope, deliverables, timeline, fee and engagement model, with assumptions and what is out of scope.
- You send
- Nothing
- You receive
- The proposal in writing
Traceable science
Every conclusion referenced to its source, ready for questions from agencies and auditors.
Direct access to the specialist
No account-management layers: the person you talk to is the person who does the work.
English or Portuguese
Documents and meetings in the language of your team and of the target agency.
Choose the format that fits your program.
Fixed-scope project
Scope, deliverables and fee defined in the proposal. Ideal for a gap analysis, an FIH package, a waiver justification or a set of CTD modules.
Ongoing support
Fractional toxicologist or NAMs radar, with a fixed monthly or quarterly fee.
Technical review
An independent opinion on documents or strategies prepared by your team or by third parties.
Every project is scoped individually.
The fee depends on the size of the regulatory question, the amount and quality of existing data, the target agencies, the deliverable and the timeline. You receive a written proposal with a defined scope and fee.
- Size of the regulatory question
- A waiver justification for a single endpoint, compared with a complete nonclinical package for FIH
- Amount and quality of existing data
- Abundant literature and organized internal data, or gaps that require search and analysis before concluding
- Target agencies
- One agency, or the FDA, EMA and ANVISA in the same project
- Deliverable
- A technical opinion, or written CTD Modules 2.4 and 2.6
- Timeline
- A regular schedule or an urgent program
- Engagement model
- Fixed-scope project, ongoing support or technical review
Frequently asked questions
Do you work with companies outside Brazil?
Yes. We work remotely, in English or Portuguese, for clients in Brazil and abroad.
How is my product data protected?
A non-disclosure agreement (NDA) is signed before any technical information is sent.
Can we sign an NDA before the first meeting?
Yes. If you want to discuss product data in the diagnostic meeting, we sign a mutual NDA before it.
Is it possible to start studies in humans without new animal studies?
In some cases, yes. When the literature and existing data are sufficient, and with the support of qualified non-animal methods, a reduced nonclinical package can be justified. D-Sci assesses your case and builds that rationale; the final decision rests with the regulatory agency.
Do you run laboratory studies?
Not directly. D-Sci designs the studies, guides the laboratories, oversees execution at the CROs and interprets the results. Execution is carried out by partner laboratories or by the CRO of your choice.
How does the fractional toxicologist work?
You contract a monthly package of hours and use it as the program needs: questions, reviews, study oversight and documents.
How long does a project take?
It depends on the scope and on data availability. The timeline is defined in the proposal.
How is the budget defined?
Each project receives a tailored proposal after the diagnostic meeting, which is free of charge.
Shall we talk about your program?
No-cost diagnostic meeting. NDA available before we talk.