Some of the consultation services MDS Pharma Services can provide include:

• Drug development for biotech companies
• Dedicated staff agreements for pharmacokinetics and statistical support
• Representation at regulatory agencies
• Many years of experience with Health Canada, FDA, EMEA, including several face-to-face meetings with regulators
• Design of studies for BE and 505b2 filings
• Collaboration on NDA documentation (biopharmaceutics section) covering nonclinical and clinical pharmacokinetics and pharmacodynamics
• Expertise on study design from phase I through IV

Early Clinical Research

Phase I-IIa

Bioequivalence Studies

PK/PD

Study Design and Protocol Development

Data Management

Statistical Analysis

PK/PD Analysis

Medical Writing and Reporting

Modeling and Simulation

Consultation