All services are tailored to our clients unique program needs. Please contact us to discuss services available for your project.
Regulatory Services
- Interact and negotiate with regulatory agencies
- Plan and guide strategic meetings:
- Pre-pre-IND
- Pre-IND
- End of Phase 1
- End of Phase 2
- CMC
- Pre-BLA
- Advisory Committee
- Use guidance’s and regulatory intelligence to streamline development programs
- Lead adversarial response (e.g., hearings, warning letter intercession)
- Design Orphan Drug and Fast Track approaches
- Target Product Profiles
- REMS
- Develop Pediatric follow-on programs
- Suggest Formulation and Indication Line Extensions
- Develop advertising, promotion and labeling
- Perform mock Inspections for both manufacturing and clinical sites
- Audit CROs
- Coordinate Advisory Committee presentations
- Guide postmarketing surveillance programs
- Biosimilars planning
Medical and Technical Writing
- Pre-pre-IND, Pre-IND Packages and INDs
- BLAs
- Orphan Drug Submissions
- Fast Track Designation Requests
- Clinical summaries and final reports
- CTDs (including eCTDs)
- Summary documents
- Special Protocol Assessment submissions
- Advisory Committee Presentations
- IMPD to IND Transformation
Manufacturing Related Services
- Analysis of excipient choices
- Formulations Assessment
- Facility assessment and submission preparation
- Review quality control procedures
- Aid in QA Investigations
- Upgrade Quality Systems
- Execute cost of goods analysis
- Review vendor contracts
- Development reports
- Audits and Inspections (US and global)
- Drug Master File generation
- Validation Master Plan development
- Change control development (pre- and post-approval)
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Clinical Development Services
- Create and Assess Clinical development plans
- Prepare clinical trials strategy
- Develop and review protocols
- Generate and Review CRF design
- Statistical Analysis Plan generation and execution
- Data Management
- Structure Adverse Experience reporting
- Draft Investigator’s Brochures
- Write and edit study reports, publications and regulatory submissions
Preclinical Programs
- Assess Needs
- Design preclinical trials
- Review protocols
- Pharmacology
- Pharmacokinetics
- Pharmacodynamics
- Toxicology
- Mutagenicity
- Single Dose
- Repeat Dose
- Toxicokinetics
- Chronic
- Reproductive
- Carcinogenicity
- Audit studies
- Assess results
- Create integrated summaries
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