Professional expertise for efficient Industrial Manufacturing in Life Sciences
Quality by design process development
Process qualification
Process validation
Risk analysis and plant design
Project management
Supervision during manufacturing campaigns
Specifications for starting materials
Specifications for in-process controls & final products
Method development
Method transfer
Process Analytical Technology (PAT)
Method qualification & validation
Quality Systems - Standard Operation Procedures (SOPs) and training programs
GMP QA management – Change, Deviation CAPA management, Batch Releases
Quality assurance for Supply Chain, GDP
GMP /GLP/ GDP Audits
QA support for facility qualification and process validation
Manufacturing Operations Quality on the shop floor
CMO and Supplier management
Raw Materials management
Authoring dossier & Regulatory commitments
Support Regulatory submissions
Post submission Regulatory support
PAI preparation and inspection management
Product launch preparation activities
Regulatory support on deviations & change control