| Regulatory
Affairs: |
| |
Explanation
of FDA regulations/expectations |
| |
Advice
on regulatory and development strategy |
| |
FDA
regulatory submission preparation/review |
| |
|
IND,
BLA, NDA, 510(k), PMA, CTD, MF, RAC submissions |
| |
Preparation
for FDA meetings and Advisory meetings |
| |
Non-US
Regulatory Submission |
| |
|
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: |
| |
|
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 |
| |
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 |
