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What We Offer
Bikorei HaKerem offers the following documentation services to its clients:
| Category | Document Type |
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Regulatory/clinical |
- Module 1 assembly + preparation of Module 2 CMC, nonclinical and clinical sections of INDs/NDAs
- Meeting packages (Pre-IND, EOPI/II, CMC; EU Scientific Advice/Protocol Assistance)
- US/EU orphan drug applications
- IND/orphan drug annual reports
- Target Product Profiles (TPPs)
- Preparation and assembly of clinical trial submission packages for the Israeli MoH
- Clinical trial protocols
- Investigator Brochures (IBs)
- Investigational Medicinal Product Dossiers (IMPDs)
- Regulatory gap analyses and strategic planning
- Regulatory Due Diligence analyses
- Pre-submission QC review of CMC, nonclinical and clinical documentation
- ClinicalTrials.gov abstracts/results preparation and updating
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R&D/academic |
- R&D and Method Development reports
- Standard Operating Procedures (SOPs)
- Scientific articles and abstracts
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