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Virtuvax provides essential guidance for development of vaccines and biologics from preclinical until marketing. Our key strengths include:
Strategy design
Design of a development strategy with the end-point in mind: a target product profile (TPP) plus Quality-TPP (QTPP) following the principles of Quality by Design (QbD) as part of an integrated development plan (IDP) including milestones, objectives, risk assessment/alternative development options and delivery on time / budget.
Pre-clinical, Chemistry, Manufacturing and Controls (CMC) and clinical Drug Development
- Non-clinical development program: pre-clinical efficacy and safety study design and execution, preclinical assay design
- Biomarker development: assay design, standardization and analytical validation in accordance with ICH guidelines; test development in accordance with medical device regulations
- Design of product development plan
- Clinical studies: (assistance in) design and scientific writing of IMPD/IND; Pharmacovigilance: design and evaluation of phase IV clinical, CRO management
Life cycle management
- Technology transfer: product/technology evaluation, feasibility study design, gap assessment and risk management, design of in-licencing / out-licensing contracts and transfer package
General expertises for interim assignments in life sciences requiring
- Line management
- Vendor management
- Project management
- Business development
Company Details
- Employees
- 1
- Founded
- -
- Address
- Ijsvogelwaard, Odijk,utrecht,netherlands
- Industry
- Biotechnology
- Website
- virtuvax.nl
- Keywords
- Vaccine Technology, Vaccine Development, Business Development, Executive Management, Consultancy.
- HQ
- Odijk, Utrecht
Virtuvax Questions
Virtuvax's website is virtuvax.nl
Virtuvax's LinkedIn profile is https://nl.linkedin.com/company/virtuvax
Virtuvax has
1 employees.
View email and phone details for 1
employees at Virtuvax.
Virtuvax's industry is
Biotechnology
Virtuvax's categories are Biotechnology
Virtuvax's founding year is 2016
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Top Virtuvax Employees
-
Ernst Soethout
Managing Director Virtuvax | Consultant…
The Randstad, Netherlands, Netherlands3hotmail.com, gmail.com, virtuvax.nl
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