Biologics Consulting Group, Inc.

The areas of expertise below covers specific activities and areas of experience
that various BCG consultants can offer.

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Regulatory Affairs

Explanation of FDA Regulations / Expectations
Advice On Regulatory and Development Strategy
FDA Regulatory Submission Preparation / Review
-	IND, BLA, NDA, IDE, 510(k), PMA, CTD, MF, RAC submissions
Orphan Drug Designation
Fast Track Designation Request
Request For Designation ( Combination Products )
Electronic Submissions
Preparation for FDA Meetings and Advisory Meetings
Non-US Regulatory Submission
-	Australia, Canada, EU, Japan, Other
Due diligence review of regulatory files

Compliance

Audits / Inspections

FDA "Mock" Inspections
-	GMP, GLP, GTP, GCP
Due diligence audits and assessments
Facility design evaluation
Pre-Approval Inspection (PAI) readiness

Quality Assurance

Quality Assurance oversight of contract services
-	Manufacturing, Testing, Toxicology
Document system development/review
Quality system evaluation/development
Computer Systems - Data Integrity / Electronic Records and Signatures
Computer Systems - Good Automated Manufacturing Practices (GAMP)

Manufacturing / Quality Control

Development/review of CMC section of regulatory submissions
Process development/technology transfer
Manufacturing operations management
Validation/qualification/optimization of:
-	Overall Validation Program Assessment
-	Drafting Validation Master Plans
-	Manufacturing processes
-	Facilities
-	Equipment
-	OTS Software with Equipment
Analytical assay development assistance/assessment
-	Identity
-	Purity
-	Potency
-	Stability Testing
-	Reference Standard Characterization
-	Test Method Qualification / Validation/Tech Transfer
Viral clearance study advice/evaluation
Cell banking advice/evaluation
-	Process / Product Comparability Protocols
Identification/oversight of Contract Manufacturing Organizations (CMOs)