Research and Development
Integâ„žal Consulting Strategies, Inc. has the experience & knowledge to tailor the perfect support to meet your needs for all veterinary pharmaceutical products at any stage of development.
New Product Development
The complexities of developing innovative products are well understood by our team. Integâ„žal Consulting Strategies, Inc. (ICSI) brings over 50 years of combined experience to your R&D needs. Our team has a unique clinical, regulatory and industry perspective tailored to improve your success and expedite time to market.
Generics
Our extensive combined knowledge of regulatory strategy to best get your proposed generic drug product to the market is unmatched.
Medical Devices
Medical device + drug combinations are tricky. Integâ„žal Consulting Strategies, Inc. (ICSI) has a strong relationship with the global regulatory community and can help you navigate the complexities of bringing your products to market.
Our R&D Services
ICSI will bring industry leading expertise to all facets of your R&D processes.
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From proof of concept to pivotal studies, we provide value-added support to your team.
Contact us to ensure your R&D identifies the best alternatives with your business, patient, end user and regulatory success in mind.
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Drug Development
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Literature reviews and white paper writing
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Technology acquisition support (due diligence)
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Strategic and regulatory consulting
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Technical and scientific support
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Product development planning
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Formulation feedback
Study Design, Documentation, Analysis and Management
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Pre-clinical and clinical protocol development
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Pharmacokinetic (PK) analysis
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Pharmacodynamic (PD) analysis
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Interpretation of study results (rodent, target species PK, PD, ADME, safety, efficacy, bioequivalence (BE), user/human food safety)
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Study report writing (interim and final study reports)
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Bilingual documentation review
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Study Management (pre-clinical and clinical)
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Quality and controls (GMP mfg. and stability testing support)
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Safety (toxicology packages and target animal safety studies)
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Efficacy (Animal models, pilot studies, pivotal studies, study design and protocols)
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Human food safety (residue depletion studies, calculation of withdrawal period/withholding times)
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Study monitoring
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Dose determination and titration
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Bioavailability
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Quality assurance and quality control
Post Approval Support
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Peer-reviewed manuscript development
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Adverse event reporting
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Line extensions (Supplemental New Drug Submissions (S/NDS) and Supplemental Abbreviated New Drug Submission (S/ANDS))
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Post NOC change filing
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Pharmacovigilance
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Monitoring
Integrating ICSI into your R&D drives regulatory success at every stage.