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
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