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Clinical Trials
Phase I–IV
From first-in-human to post-marketing studies.
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Preclinical / Non-Clinical
Tox & Safety
Toxicology, genotoxicity, and safety pharmacology.
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BA/BE & PK Studies
Regulatory
Bioavailability, bioequivalence, and pharmacokinetics.
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Analytical & Stability
ICH / GLP
Method development, validation, and stability testing.
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Regulatory Support
GLP · CDSCO · FDA
Compliance and dossier preparation for submissions.
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Medical Writing
CSR · Protocol
Clinical study reports and regulatory documents.