Comprehensive Drug Development Services in New York

Orphan Drug Services, Inc. stands at the forefront of cutting-edge biotech consultant practices. Our dedicated team carries a revered legacy of providing comprehensive drug development services in New York that are unmatched in precision and quality. We take pride in our meticulous approach, tailoring every aspect of the drug development lifecycle to meet the needs of our clients.

Your Strategic Partner from Bench to Bedside

Our array of services encompasses the entire spectrum of drug development. We excel at navigating complex regulatory environments, crafting lucid scientific documentation, delving into in-depth statistical analysis, and mastering pharmacokinetics.

Our strategic prowess is designed to accelerate your journey from conceptualization to real-world application, ensuring that groundbreaking biologics reach the market swiftly and securely.

Transformative Biologics Through Collaborative Excellence

As your biotech consultant, Orphan Drug Services, Inc. is deeply committed to transforming innovative scientific breakthroughs into therapeutic solutions that alter the course of patients’ lives. Embrace the opportunity to join forces with us — a partnership where audacious goals are the norm and turning the impossible into the tangible is our mutual ambition.

For a detailed exploration of how our services can support and enhance your drug development ventures, we warmly invite you to reach out. Together, let us navigate the path to success and illuminate the future of healthcare with transformative drug therapies.

Regulatory Strategy and Scientific Writing

  • Clinical Trial Protocols
  • Investigator Brochures
  • Drug Applications (IND/NDA/aNDA/sNDA)
  • Orphan Drug Applications (ODA)
  • Meeting Requests
  • Meeting Request Packets
  • Statistical Analysis Plans (SAP)
  • Clinical Study Reports (CSR)
  • Pharmacy Manuals
  • Regulatory Strategy and Scientific Writing
  • Clinical Trial Protocols
  • Investigator Brochures
  • Drug Applications (IND/NDA/aNDA/sNDA)
  • Orphan Drug Applications (ODA)
  • Meeting Requests
  • Meeting Request Packets
  • Statistical Analysis Plans (SAP)
  • Clinical Study Reports (CSR)
  • Pharmacy Manuals

Statistics

  • Statistics Services
  • Study Design 
  • Protocol Development
  • Statistical Analysis Plans (SAPs)
  • Analysis Dataset Development
  • Data Cleaning
  • Statistical Tables
  • Data Listings
  • Figures
  • TLFs
  • Randomization
  • Sample Size Estimates
  • Reporting for Data Review Committees
  • Drug Safety Monitoring Boards
  • Institutional Review Boards
  • Formulation Screening
  • Formulation Equivalence
  • Statistics Services
  • Study Design 
  • Protocol Development
  • Statistical Analysis Plans (SAPs)
  • Analysis Dataset Development
  • Data Cleaning
  • Statistical Tables
  • Data Listings
  • Figures
  • TLFs
  • Randomization
  • Sample Size Estimates
  • Reporting for Data Review Committees
  • Drug Safety Monitoring Boards
  • Institutional Review Boards
  • Formulation Screening
  • Formulation Equivalence

Pharmacokinetics

  • Pharmacokinetic Data Analysis
  • Pharmacodynamics
  • Bioequivalence
  • Clinical Equivalence
  • Simulations
  • Parameter Comparisons
  • Figures
  • Report Summaries
  • Sample Size Estimates
  • Pharmacokinetic Data Analysis
  • Pharmacodynamics
  • Bioequivalence
  • Clinical Equivalence
  • Simulations
  • Parameter Comparisons
  • Figures
  • Report Summaries
  • Sample Size Estimates