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Trust
Respect
Understanding
Team-work
Honesty
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Patiently we listened, we
observed and we learned
and now we are more
powerful than ever
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Management Consulting &
Technology Services
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Healthcare & Pharmaceuticals
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- Global product strategy planning
- Preclinical development planning
- Program management
- Project management
- Quality management
- Documentation
- Protocol development
- Regulatory strategies
- Technical consulting
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- Research and Drug Discovery development
(R&D)
- Chemistry, manufacture and control (CMC)
section development
- Preclinical drug development and
management
- Technical Writing
- Quality Assurance
- Regulatory services
- Safety Services
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Pre-clinical drug development
- Pharmacology
- Safety pharmacology studies
- Toxicokinetics and toxicodynamics
- Analytical and bioanalytical method
development and analysis
- Review and interpret complex pre-clinical
data
- Protocol Development/Study
Monitoring/GLP Audit
- Document generation, including writing
SOPs, analytical methods, assay
validation and bioanalytical reports,
documents for regulatory submissions,
and manuscripts
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Research and Drug Discovery
- Chemistry, manufacture and control (CMC) development
- Quality Control management
- Clinical Research Development
- Regulatory strategies
- Quality Assurance
- Global product strategy planning
- Safety Services
- Project management
- Documentation
- Protocol development
- Technical Writing
Drug Research and Discovery Services
- Assay development
- High-throughput screening
- Lead optimization chemistry
- Retrieval and analysis of relevant literature
- In vitro ADME and pharmacokinetic studies
- Safety pharmacology studies
- Toxicokinetics and Toxicodynamics
Drug Development Services
- Pre-formulation
- Formulation development strategy for both API and formulated drug product
- Analytical Method Development
- Analytical Method Validation
- Raw material selection and GMP drug product manufacture and technology transfer
- Packaging, labeling and distribution
- Process Development
- Stability
- Microbiology
Drug Manufacturing
- Semi-solids and Liquids
- Steriles
Regulatory Services
- Preparation of pharmacology, pharmacokinetic and toxicology sections for regulatory submissions
- Review and consultation on non-clinical and regulatory issues affecting submissions
- Preparation of CMC sections for regulatory submissions
- Preparation of amendments, supplements and annual reports for regulatory submissions
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