Biopharmaceuticals Consulting Group
Regulatory and Compliance
We provide you services for:
- Regulatory submissions for product
licensing In U.S. And International
- IND, BLA, NDA, MAA, CTD
- Comparability protocols and Reports
- Stability reports
- Clinical reports
- Drug Safety reports
- Submission of Post-approval changes
- Preparation for Pre- and Post-approval
Inspection
- Auditing and Supplier management
systems
- Licensing Facilities
- Annual Reports
- Science based interpretation of rules
and regulations
- Product Complaints
- Pharmacovigilance
GMP and GLP Compliance for Clinical and Commercial Products
We provide:
- Basic GMP Training
- Specific GMP training
- Training for System-based inspection
- GLP Training
- GXP training
Required Quality Systems for each product stage
- Change Control
- Validation, Qualification
- Technology Transfer
- Documentation
- Training
- Material tracking
- Release
- Laboratory systems
- Outsourcing
Customized in-house training according to your needs
QA Systems
Will assist you to implement systems for:
· Documentation
· Auditing
· Inspections
· Annual Product Review
· Training
· Deviations
· Supplier Management and Vendor Qualification
· Product Release
· Investigations
· Change Control
· Material tracking and disposition
QC Systems
Will establish all laboratory systems for you:
· Training
· Documentation
· Method development and validation
· System Validation
· Instrument Validation and qualification
· Stability
· Standards
· Microbiological validation
· Environmental Monitoring
· Alert/action notification
· Establishing Meaningful Specifications
· Technical Evaluation
Process Development and Manufacturing
We provide consulting services for all your needs
in :
· Product Characterization
· Process validation
· Process monitoring
· Process Analytical Technology
· Technology transfer
· Change Control
· Technical evaluation
· Material tracking
· Facility validation
· Investigation
Biopharmaceuticals
Consulting Group