Our Services
TLR TECH Clinical Research Professionals are expert in
- Medical Writing
- Clinical study protocols (all study phases and variety of study designs)
- Clinical study reports (ICH-E3 and abbreviated formats)
- Clinical sections of regulatory submissions (IND, NDA, BLA and MAA in CTD format)
- Investigator's Brochures
- Risk Management Plans for EU, Canada, Australia, Japan and China
- Orphan drug applications in US and EU
- FDA briefing packages
- Development Safety Update Reports
- Paediatric investigational plans
- Strategic and Regulatory Consultation in collaboration with US Regulatory Experts
TLR TECH fully complies with international regulatory requirements (e.g., ICH E6 and E3 guidelines).
TLR Tech's Clinical Research Professionals have advance life-science degree, experience in most therapeutic areas and worked extensively in the following fields:
- Central Nervous System
- Anti-infectious Diseases
- Oncology
- Endocrinology
- Anti-infective
- Immunology
- Dermatology
- Respiratory
- Metabolic disroders
- Women's health
TLR TECH also works closely with highly experienced clinical monitors and collaborates with US and European regulatory experts to provide its customers a broader range of clinical and regulatory consulting services.We would be happy to refer you to these consultants as a courtesy service.
For a competitive price proposal
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