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 |
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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 |
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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 |
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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) |
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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) |
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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) |
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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 |
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Biostatistics
| Explanation of FDA expectations |
| Statistical evaluation of clinical trial design |
| Statistical issues for assay design |
| Preparation of integrated statistical and clinical reports |
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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 |
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Training
| In-house training. Pre-developed courses and development of specialty courses |
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