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