Professional Consultation and Regulatory Document Delivery
Our regulatory affairs professionals ensure compliance with current regulations, develop and deliver supporting regulatory documents, consult with regulatory agencies, and provide strategic and technical advice to your company to resolve any regulatory challenge. For instance, we can:
- Prepare, review and file regulatory dossiers/submissions
- Act as the Regulatory Representative
- Liaise with regulatory agencies on procedural, CMC, clinical and toxicology matters
- Respond to regulatory agency questions
- Provide expert regulatory GXP compliance advice throughout development
- Assist with due diligence activities for investors/licensees
The ITS Inc. regulatory affairs, biostatistics, medical writing teams and MDs work collaboratively to build the needed regulatory documentation for your product as needed for its phase of developent. Our team can prepare:
- Preclinical And Scientific Reports
- Investigator Brochures
- Briefing Documents for FDA meetings and EMA Scientific Advice
- Phase I-IV Clinical Protocols and amendments
- Informed Consent Forms/Patient Information sheets
- Phase I-IV Statistical Analysis Plans (SAPs)
- Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs)
- Clinical Trial Amendments, Notifications and Annual Reports
- Fast Track Requests
- Requests for Orphan Drug Designation
- Investigational Device Exemption (IDE) Applications
- 510(k)s
- Integrated Summaries of Safety/Efficacy
- New Drug Applications (NDAs)
- Biologics License Applications (BLAs)
- Patient Safety Narratives
- Premarket Approval (PMA) Applications
- Post approval variations
Medical Writing is core to all ITS’s services. Our team of medical writers works with other experienced professionals to develop regulatory, safety and post-approval documentation that align with our partner’s objectives.
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