About Us

Specializing in Drug Delivery Development and Clinical Study Design & Operations

Mesa Science Associates, Inc. provides a comprehensive array of pharmaceutical development solutions to the research community including the Federal Government. From product development planning to NDA or BLA submission, our flexible service model leverages a network of highly skilled research and research support professionals from across the US. Our network includes professionals from all aspects of pharmaceutical development activities including:

  • Formulation Services – active pharmaceutical ingredient (API), formulation and assay development;
  • Pre-clinical Services – animal model development, study design, study report review and finalization, and project management oversight;
  • Clinical Services – operational expertise in study conduct of Phase I through IV clinical trials, project management oversight, clinical study report review and finalization;
  • Regulatory Services – IND preparation and submission through NDA filing;
  • Manufacturing Services – development of CMC sections including drug container closure systems, design of drug stability programs and final drug delivery system configurations.

 

Detailed Services

Formulation Development

  • Selection and qualification of API sources
  • Bio-assay development
  • Drug assay development

Pre-Clinical

  • Development of baseline animal models
  • Design of experiments
  • Toxicology

Pharmacology

  • Pharmacokinetics
  • Pharmacodynamics
  • Drug-drug interaction studies
  • Special populations

Regulatory Services

  • IND and NDAs
  • Protocol submissions to IRBs

R&D Program Management

  • Protocol development
  • Project financial management
  • Clinical trial monitoring & auditing
  • Training materials & program development
  • Report writing
  • Investigator identification
  • Medical monitoring

Key Differentiators

  • Our Experience
  • Our Scientific Expertise
  • Our Integrated Solution Teams Approach
  • Our Client Relationship Focus

Specialized Experience

  • Focus Groups and User Studies
  • FMEA Procedures
  • Pharmaceutical Manufacturing
  • Drug delivery systems
  • Auto-injectors
  • Pre-filled syringes
  • Vaccines

Company Data

  • DUNS 969595086
  • CAGE 6KAX1

NAICS

  • 541711
  • 541712
  • 541690
  • 325412

Veteran Owned Small Business