Full feasibility study :
Potential, Portfolio, Plant , Model, SWOT, Phasing, ROI with projected P & L (360D) .
Turnkey Project Execution:
Product development and Project implementation
Support for Products/Technology at various stages :
Finished Product, Formulated bulk, concentrated bulk, Drug Substance
Gap Analysis for existing facilities :
Product, process, Plant, people.
Build of QMS :
SOP’s, validation, EMP, Risk assessment, CAPA
Support :
for Validation batches, Stability, Clinical trials & CTD dossiers
GMP audits :
Pre-inspection / Compliance/ Routine,
Product Development :
for US, Europe and other global markets for API and Formulation.
Regulatory strategies :
US-ANDA/EU-MAA/ROW-Dossier/ASEAN CTD/ Type –II DMF/ASMF/CEP/query handling etc.
Product Design
Expertise in a IT consultancy for the many companies, for their different working areas.
IT Consultancy
Expertise in a IT consultancy for the many companies, for their different working areas.
Digital Services
Expertise in a IT consultancy for the many companies, for their different working areas.