Sharing our expertise
Our consulting services
We are glad to share our expertise in pharmaceutical quality, regulatory affairs and drug development.
THROUGH THE WHOLE DEVELOPMENT
We manage every aspect
Quality Assurance
- Risk management
- QP declaration
- Supplier & contractors auditing and many more…
Regulatory strategy
- CMC expertise
- Full /abridged application (hybrid, generic, WEU) strategy
- Scientific advice (EU/US) and many more…
Drug Development
- Integrated development plan aligned with regulatory strategy
- Project management
- Grant application and many more…
Interim Management
- Senior Interim Management in the fields of expertise
- Qualified Person
Innovation Landscape Insights
- Trends around specific technology (including patent data evaluation)
- Understand competitive landscape with visualizations
Drug development
From plans to project management
- Integrated development plans aligned with regulatory strategy
- Project planning
- Project Management
- Face to face meeting with EMA (or national agencies) and FDA
- Grant application writing
- Minimize risk, accelerate timelines and avoid pitfalls throughout the drug development continuum
Regulatory affairs
Conducting Regulatory Strategies
- Full or abridged (generic, hybrid, well established use) applications in EU and in US
- Conducting Regulatory Due Diligence audits
- CMC Expertise
- Development of Regulatory Strategies for new and Existing Products, complex therapeutics
- Face-to-face meeting with EMA (or national agencies) and FDA
- Life Cycle Management
Quality Assurance
Ensuring pharmaceutical quality
- Strategic and operational Quality Assurance Consultation including Good Manufacturing and Distribution Practice
- Obtaining and maintenance of Manufacturer’s/Importer’s Authorisations and Wholesale Dealer’s Authorisations
- Preparation of QP Declarations
- Consultant Responsible Persons on Wholesale Dealer’s Authorisations
- Supplier and Contractor Auditing – end to end management of audits, CAPA plans and audit closure
- Quality Risk Management
Interim Management
In the fields of expertise of QA, RA and drug development
- Senior Interim management for Quality Assurance and Regulatory Affairs roles in small and medium research-based companies and contract development and manufacturing organisations (CDMO). Contracts are undertaken on a short- or long-term basis, depending on client requirements.
- Consultant Qualified Persons on Manufacturer’s/Importer’s Authorisations for both commercial and Investigational Medicinal Products
- Trainee QP Mentoring
INNOVATION LANDSCAPE INSIGHTS
Innovation Landscape and Competitive Intelligence
- Trends around specific technology (including patent data evaluation)
- Understand competitive landscape with visualizations, such as major players in the market or filing trends
Contact us
Befve 22
4890 Thimister
+32 476 700 214
aliusmodi@outlook.com