Celogen Group through it’s team of highly qualified professionals offers valuable services in the Pharmaceutical Sector.
Our team of Professionals offer services in the following are as:
- Setting up a Green Field Project for Pharmaceutical Formulation.
- Setting up a New API / Intermediate Plant
- Consultancy on cGMP.
- Up gradation of Existing Facility for Stringent Regulatory Approvals.
- Assisting in Regulatory approvals (Query Satisfaction) from Europe, USA and other Regulated Markets.
- Technical assistance / Problem solving in Quality related Issues.
- Product Development and Dossier Making / Compilation.
- Assistance in Clinical Trial / Bio-Equivalence study.
- Third Party Bio equivalence Study monitoring
- New Process Development in Formulation and API.
- Analytical Method Development and Method Validation
- Assistance in Process Validation
- Conducting Stability Studies on a long-term basis.
- Marketing of Formulations in Global Market.
- Out-Licensing of Dossiers and Registrations in Regulated Market.
- Arranging Site Transfer for better Product Efficiency and achieve better Cost Effectiveness.
- Launching of Products in Global Markets.
- Assisting companies to launch products in Regulated Markets – USA, Europe, Canada, Australia, South Africa etc.
- Third party GMP Inspections for API and Drug Product Manufacturing