Areas of work
Specific project data is not disclosed for confidentiality reasons. Below are the typical tasks and situations we work with.
What clients come with
Each project is unique, but the tasks are often similar. Here are the most common situations.
Defining the registration route
Mapping the path from development to registration: what studies are needed, in what order, and what risks each stage carries.
- Drug profile analysis
- Registration strategy selection
- Project risk map
Document review before submission
The company completed dossier preparation — an expert review from the regulator's perspective is needed before submission, while weak points can still be addressed.
- Clinical section analysis
- Risk zone identification
- Strengthening recommendations
Preparing CT documentation
Developing protocols, investigator brochures, and clinical dossier sections per current EAEU requirements.
- Clinical trial protocols
- Investigator brochure
- Clinical section of the OTD
BE strategy and documentation
Defining study design, selecting the reference drug, preparing documents, and calculating dissolution profiles.
- BE study strategy
- Reference drug justification
- DSSP calculations
Preparing responses to objections
Regulatory objections received — we help formulate the position, prepare the response, and additional materials.
- Objection analysis
- Position formulation
- Dossier supplement preparation
Subcontract for КИО and labs
A contractor took a project with a regulatory component requiring deep expertise. We join confidentially, without risk to client relationships.
- Confidential involvement
- Closing the complex component
- Pre-delivery client support
Your project is unique
We approach each task individually. Tell us your situation — we'll figure out the right format together.
Discuss a project