Area Of Expertise

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
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IND, BLA, NDA, 510(k), PMA, CTD, MF, RAC submissions
Preparation for FDA meetings and Advisory meetings
Non-US Regulatory Submission
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EU, Australia, Canada, Japan, etc.
Due diligence review of regulatory files

Compliance
Preparation of responses to FDA 483 citations and warning letters
Import/export issues
Injunction/seizure/consent decree issues
Promotional labeling and advertising issues
FDA dispute resolution processes
Assistance with CE Marking Certification and Surveillance Inspection Reports

Audits / Inspections
FDA "mock" inspections (GMP, GLP, GTP, GCP, pre-market approval for devices, ISO certification, Quality System Review)
Due diligence audits and assessments
Facility design evaluation
Pre-Approval Inspection (PAI) readiness

Quality Assurance
Quality Assurance oversight of contract services (manufacturing, testing and 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:
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Overall Validation Program Assessment
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Drafting Validation Master Plans
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Manufacturing processes
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Facilities
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Equipment
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OTS Software with Equipment
Analytical assay development assistance/assessment
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Identity, purity, potency, stability testing
Viral clearance study advice/evaluation
Cell banking advice/evaluation
Identification/oversight of Contract Manufacturing Organizations (CMOs)

Preclinical Safety Testing
Development/review of Pharmacology/toxicology sections of regulatory submissions
Pharmacology/Toxicology program development/planning/assessment
Pharmacology/Toxicology study protocol development/assessment
Due diligence assessment of new products
Review and assessment of pharmacology/toxicology study results
Pharmacokinetics and biodistribution study analysis/review/assessment
Identification/oversight of Contract Testing Organizations (CTOs)

Project Management
Strategic Planning and Business development
Development of timelines, budgets, and personnel requirements for tech transfer
Selection, costing and placement of manufacturing/research equipment
Vendor Management

Biostatistics
Explanation of FDA expectations
Statistical evaluation of clinical trial design
Statistical issues for assay design
Preparation of integrated statistical and clinical reports

Clinical
Development/review of clinical section of regulatory submissions
Clinical program development strategy
Clinical protocol development/review
Clinical trial design and product development plans
Clinical trial report preparation/review
Post marketing requirements, accelerated approval, surrogate endpoints
Comprehensive "FDA" style review of safety and efficacy data
Assist with the conduct of clinical trials
Consultation regarding clinical and public health issues as they pertain to the development of new products and clinical trials

Training
In-house training. Pre-developed courses and development of specialty courses

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