SERVICES
PROVIDED INCLUDE:
SCIENTIFIC / TECHNICAL
CONSULTATION
- Regulatory
Requirements
Safety assessment and registration.
- Protocols/Experimental
Design
Preparation/review.
- In-Life
Phase
Monitoring and data analysis/interpretation. - Necropsy
Supervising/attending. - Histopathology
Examination and interpretation of findings. - Pathology
Reports
Preparation/review.
- General
Study Reports
Preparation/review. - Peer Review
(Independent Party Opinion)
Of all phases of studies. - Electronmicroscopy
Examination and interpretation of findings. - Quality
Assurance/GLP Compliance
Of all phases of studies. - Toxicology
Summaries/Executive Summaries/Drug Resumes/Manuscripts
Preparation/review. - Documents
for Regulatory Submission (INDs, NDAs, PLAs, etc.)
Preparation/review. - Client
Representation
At regulatory agencies, contract research organizations,
etc.
MANAGERIAL CONSULTATION
SERVICES:
- Efficient and
focused approach to problem
solving, integrated with the business needs
of the client.
- Link toxicology-pathology
with the demands
of discovery/clinical development/post-marketing
issues.
- Implement and
monitor the coordination
of interdisciplinary functions.
- Network to
academia, contract research organizations and other experts.
- Tap into international
professional affiliations.
- Affiliate organizations
and consultants to
combine expertise in medical chemistry, peptide synthesis, analytical (GMPs),
formulations, metabolism/pharmacokinetics, clinical pharmacokinetics,
statistics, medical writing, regulatory affairs, marketing, and trade
relations.
OTHER CONSULTATION SERVICES:
- Analysis of strengths
and weaknesses
in litigation.
- Availability of expert
reports and testimony.
- Development of training
curricula.
- Availability of trainers/instructors.
- Assessment, development
and application
of research support products.