Qualix Services
Around the world
Business Management & Development
- Develop Business planning and Strategies
- Evaluate business development opportunities and negotiate deals
- Pharmaceutical project feasibility assessment
- Technology transfer strategies
- Conduct Mock Audits for Inspection readiness
- Lead end to end Greenfield project planning to execution / Commissioning/Qualification
Technical Assistance
- Manufacturing and Quality improvement programs
- Deploy Proactive Quality programs
- Kaizen -Technical assistance in developing Stability study program
- Clinical study regimes, bioequivalence studies and registration requirements
- Training matrix & curriculum
Manufacturing assistance
- Scout and Qualify suppliers
- Scout and Qualify CMO/TPM facilities
- Flawless setup of manufacturing equipment’s and conclude on Qualifications
- Flawless setup of Analytical and Micro lab
- Conduct trials and conduct process validation
- Conduct Process FMEA and site risk assessment
- Support on Machine process capability assessment
Licensing and MAH responsibilities
- Support on Dossier preparation and submission
- Support on Licensing activities
- Conduct periodic Due diligence of Product portfolio throughout the product lifecycle
- Drive DC compliance, Commercial strategy development, and export readiness