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Expertise

Chemical Drugs & Biologics

Comprehensive development support from preclinical strategy through regulatory approval for small molecules and biologic therapeutics.
Core Services

  • Phase 1 Clinical Pharmacology
    – First-in-Human (FIH) study design: SAD, MAD, PK/PD characterization
    – ADME studies: bioavailability, food effect, drug-drug interactions
    – Special population PK: renal/hepatic impairment, elderly, pediatric
    – Bioequivalence and biosimilarity studies
  • Phase 2-3 Clinical Development
    – Proof-of-concept and dose-ranging trials
    – Pivotal efficacy and safety studies for marketing authorization
    – Global multi-regional clinical trials (MRCT)
    – Adaptive designs and seamless phase transitions
  • Regulatory Strategy & Submissions
    – IND/CTA preparation and health authority pre-submission consultations
    – Marketing authorization applications (NDA/BLA/MAA)
    – Regulatory deficiency response and advisory committee preparation
    – Expedited pathways: breakthrough therapy, fast track, PRIME designation
  • Small Molecule & Antibody Expertise
    – Monoclonal antibodies and antibody-drug conjugates (ADCs)
    – Bispecific antibodies and multi-specific constructs
    – Fusion proteins and recombinant therapeutics
    – Novel formulations and drug delivery systems

Advanced Therapy Products

Specialized development and regulatory strategies for cell therapies, gene therapies, and tissue-engineered products.
Core Services

  • ATMP Development Strategy
    – Cell therapy (CAR-T, TIL, MSC, iPSC-derived) clinical development
    – Gene therapy (AAV, lentiviral, non-viral vectors) program design
    – Tissue-engineered products and regenerative medicine strategies
    – Manufacturing comparability and CMC-clinical bridging
  • Long-Term Safety Monitoring
    – Long-term follow-up (LTFU) protocol design and execution (up to 15 years)
    – ATMP Risk Management and Investigation (ARMI) framework implementation
    – Delayed adverse event monitoring and reporting systems
    – Integration with national registries and surveillance networks
  • Specialized Study Management
    – Investigator-initiated LTFU studies and investigational site coordination
    – Patient registry development, enrollment, and long-term data collection
    – Post-marketing commitment (PMC) study design and execution
    – Real-world evidence generation for ATMP lifecycle management
  • Regulatory Navigation
    – RMAT/PRIME/SAKIGAKE designation and expedited approval pathways
    – Potency and comparability strategy for manufacturing changes
    – Conditional approval and post-authorization safety study (PASS) planning
    – Pediatric investigation plans and extrapolation strategies

Medical Devices

Regulatory strategy and clinical investigation design for medical devices, digital therapeutics, and software as medical devices.
Core Services

  • Device Expertise Across Modalities
    – Aesthetic Devices: Fillers, botulinum toxins, lifting threads, lasers, energy-based devices (RF, ultrasound, cryotherapy)
    – Digital Health: AI/ML-based SaMD, remote monitoring platforms, prescription digital therapeutics (DTx)
    – Therapeutic Devices: Implantables, wearables, neurological stimulation, pain management systems
  • Clinical Investigation Programs
    – Safety, performance, and effectiveness studies for regulatory submissions
    – Pivotal trials for CE marking (EU MDR), FDA 510(k)/PMA, and MFDS approval
    – Post-market clinical follow-up (PMCF) and real-world performance studies
    – Comparative effectiveness research and non-inferiority designs
  • Regulatory Strategy & Submissions
    – Device classification and optimal regulatory pathway selection (FDA/MDR/MFDS/PMDA)
    – Clinical evaluation reports (CER), equivalence assessments, and gap analyses
    – Pre-submission consultations and scientific advice meetings
    – Technical file preparation and notified body interactions
  • Study Operations & Quality Assurance
    – Independent evaluator (IE) selection, and blinded assessment management
    – Photography protocols and standardized outcome measurement
    – Adjudication committee oversight and endpoint validation
    – GCP compliance, monitoring, and regulatory inspection readiness

In Vitro Diagnostics

Analytical and clinical validation studies for IVD regulatory approval and market authorization across global jurisdictions.
Core Services

  • IVD Expertise Across Diagnostic Platforms
    – Diagnostic test development across multiple platforms and methodologies
    – Laboratory-developed tests (LDTs) and commercial assay validation
    – Companion diagnostics (CDx) for precision medicine applications
  • Analytical Performance Evaluation
    – Analytical validation: Precision, accuracy, LoD/LoQ, linearity, interference, stability
    – Verification studies and method comparison protocols
    – Specimen collection, handling, and storage validation
  • Clinical Performance Studies
    – Clinical validation: Sensitivity, specificity, positive predictive value (PPV)/negative predictive value (NPV), diagnostic accuracy
    – Prospective and retrospective study design and execution
    – Intended-use population studies and real-world clinical utility evaluation
  • Regulatory Strategy & Submissions
    – FDA (510(k)/De Novo/PMA), IVDR (Class A-D), MFDS, PMDA pathway optimization
    – Performance evaluation reports (PER) and clinical evidence documentation
    – CDx co-development strategies and breakthrough device designation support

Post-Market Surveillance

Ongoing safety monitoring, adverse event reporting, and regulatory compliance for marketed products across therapeutic areas.
Core Services

  • Safety Monitoring Programs
    – Post-marketing surveillance (PMS) program design and execution
    – Adverse event data collection and trend analysis
    – Long-term safety follow-up and delayed adverse event monitoring
    – Product quality complaints and device deficiency reporting
  • Post-Market Clinical Studies
    – Medical device post-market clinical follow-up (PMCF) studies
    – Non-interventional studies (NIS) and observational safety research
    – Post-authorization safety studies (PASS) for regulatory commitments
    – Comparative safety evaluations and benefit-risk assessments
  • Registry Development & Management
    – Patient registry design, establishment, and long-term operation
    – Disease-specific and product-specific registry strategies
    – Multi-site registry coordination across domestic and international locations
    – Registry data integration with regulatory reporting requirements
  • Regulatory Compliance & Reporting
    – Post-market surveillance report preparation and submission
    – Periodic safety update reports (PSURs) and aggregate data analysis
    – Health authority inspections readiness and documentation support
    – Post-approval commitment fulfillment and milestone tracking

Clinical Performance & Evaluation

Real-world evidence-based studies for regulatory approval, product certification, and health insurance reimbursement support.
Core Services

  • Real-World Evidence (RWE) Generation
    – Clinical performance studies using real-world data (RWD) for effectiveness analysis
    – Comparative effectiveness research and treatment pattern studies
    – Health technology assessment (HTA) evidence preparation
    – Post-launch performance monitoring and ongoing benefit-risk evaluation
  • User Experience & Usability
    – Human factors and usability evaluation for medical devices and digital health
    – User interaction studies and interface optimization
    – Digital device user behavior analysis and engagement metrics
    – Patient-reported outcomes (PRO) and quality of life assessments
  • Regulatory Support
    – Clinical evidence packages for product certification and market expansion
    – Post-market clinical follow-up (PMCF) integration with RWE programs
    – Label expansion and indication extension evidence strategies
  • Market Differentiation Studies
    – Clinical studies designed for brand positioning and marketing claims
    – Comparative product performance evaluations
    – Before-and-after outcome documentation with independent assessment
    – Clinical messaging derivation from evidence-based endpoints