QMS Documentation: ❏ Extensive documentation experience ❏ Technical reports for multiple experiments ❏ Standard operating procedures (SOP) for laboratory and manufacturing equipment ❏ Quality control methods and stability protocols ❏ IQ/OQ/PQ records for laboratory and manufacturing equipment ❏ Process development/validation documentation ❏ Master batch records in Phase I, II, III drug manufacturing for R&D, GxP, and EU regulations GMP Manufacturing: ❏ Vast knowledge and experience in the manufacturing of drug products ❏ Solid and liquid oral dosage forms ❏ Parenteral sterile dosage forms, including lyophilization ❏ Drug-excipient interactions ❏ Formulation optimization with process development/validation ❏ Controlled release systems, micro-emulsions, micro-encapsulations, vaccines and transdermal drug products ❏ Manufacturing multiple drug products for Phase I, II, III studies, under cGMP US/EU compliance