Our Services

“Tomar BioLife Consultancy offers a full spectrum of support for biotech companies, guiding projects from preclinical stages through regulatory submissions for first-in-human(FIH) and early-phase clinical trials.”

Preclinical Studies

    • Preclinical efficacy studies
    • Primary and secondary pharmacology studies
    • Toxicology and safety studies

Clinical Development Support

      • Biomarker and bioanalytical (PK/PD/Immunogenicity) support for FIH (First-in-Human) studies
        1. Method development (Small and large molecule)
        2. Qualification and/or validation
        3. Clinical Bioanalysis
      • Data collection and analysis for early-phase clinical programs

Regulatory Support

    • Regulatory documentation (IB and IMPD)
    • Orphan drug designation (ODD)
    • Regulatory communications with EMA (SA and PA meeting) and FDA (Type B like pre-IND and type C meetings)

Operational Consultation

      • CRO/CDMO selection and management
      • Vendor management for clinical and preclinical programs
      • Data collection and vendor coordination for regulatory submissions

Strategic Consulting

    • Development strategy and planning
    • Program feasibility studies
    • Regulatory strategy and interactions with regulatory bodies
    • Risk assessment and mitigation

Management Consulting

    • Project and portfolio management with timeline optimization
    • Financial planning and resource allocation
    • Stakeholder management and communication

Call to Action

Partner with Us for Biotech Success

Call to Action
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