Medical Affair

Interim Executive or Chief Medical Officer (CMO)

Study Protocol Review (second opinion)

Protocol Amendment (improve performance)

Cost-Efficient Study Design

Clinical and Regulatory Strategy

Clinical Development Roadmap

Key Opinion Leader (KOL) and Advisory Board Meeting

Orphan Therapeutic (A to Z)

Clinical Data Interpretation for decision making

Medical Monitor

CSR, IB, Protocol Development, and more

Biomarker Evaluation & Selection

Technology Assessment

CRO Management

Biologics & Biosimilars Development

Regulatory Affair

Pre-IND and IND Package and Meeting Preparation

Pre IDE and IDE Package and Meeting Preparation

Orphan Petition FDA & EMA

Combination Products

505(b)(2) Submission

End of Phase I and II regulatory meetings

Scientific Advice for Biosimilars at EMA

FDA & EMA Teleconference & in-person Meetings

Regulatory development path and strategies

Safety & Pharmacovigilance

Risk Management Plan (RMP)

IND Annual Safety Update

Development Safety Update Report (DSUR)

Causality Assessment

Clinical Trials & Post-Marketing Case Review

Safety Surveillance & Signaling

Analysis of Similar Events for AEs of Interest & SUSARs

SAEs Assessment & SUSARs Reporting

NDA Summary of Safety for Biologics & Small Molecule

AE Coding

Core Safety Information Development

Independent Drug Monitoring Committee (DMC)