Help your company deliver the qualitative and quantitative information necessary to be compliant and efficient, enabling you to be focused on your core business
Nuklio
All around Pharma
Nuklio
From R&D to Regulatory Affairs or Pharmacovigilance
The core of your information
Our solutions
A comple perception
Quickly navigate through our system and have 360º perception of the entire product history and projects
Improved team coordination
Manage projects and people in a simple and swift way, improving your team coordination
Data-driven decisions
Access a KPI and report dashboard that helps make data-driven business decisions
All data in one place
Centralize all data, understand process bottlenecks and reduce the loss of information and risk of non-compliance and audit failure
Our mission
Our Modules
Four different modules, all the information
Four modules that will cover all your technical activities
Research and development
Manage data, projects, project owners, milestones and KPIs in a single platform, making conscious and informed business decisions focused on efficiency and increased compliance.
- Keep project Stakeholders clearly identified
- Set and Analyse customized product development milestones
- Link relevant R&D Documentation
- Tracking of decisions and discussion on ongoing projects
- Track supporting information on clinical studies detailsItem da lista
- Detailed project reporting including a timeline overview
- Easily relate product development batches with stability studies information
- Comprehensive and secure audit trial capturing
Regulatory Affairs
Our platform will help you through all types of Regulatory Procedures guarantying compliance and a much easier management.
- Automated features to populate relevant product data
- EMA standard reference framework Substance, Product, Organisation and Referential (SPOR) master data support
- Manage your Product Information. (SmPC, PIL and Labelling)
- Easily start and manage regulatory activities (new MA, variations or submissions) through a project management tool
- Keep track of regulatory timelines
- Predefined templates with project steps for Regulatory Activities
- Track submission activities and progress
- Resource management: who is working on what?
Pharmacovigilance
Be able to perform all the pharmacovigilance activities related to Safety and manage all the applicable data in a single, shared, updated and communicative platform.
- Electronic communication with EMA E2B gateway
- Adverse events management database
- Management of PSUR and RMP
- Signal detection
- Management of Literature Screening
- Compliant with relevant drug safety regulations and regulatory guidelines
- Import/export of XML data
Quality assurance
Manage all Quality Procedures and Processes that interfere with your products lifecycle, from Product Studies to Supplier Management. A unique vision on Quality, a simpler way to be compliant.
- Stability Studies – Plan, Execute and Report Results
- Supplier Management – From Initial Qualification to continuous evaluation
- Change Control Management – A tool used by all departments, centralized on the product
- Document Management System
- Human Resources Management System – Training Control and Staff Management
- Audit Planning
Contact us
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IPN Incubadora,
Rua Pedro Nunes, 3030-199 Coimbra,
Portugal - info@cerinio.com
- (+351) 239 781 014
