BSc in Biochemistry,
MA in Organic Chemistry
15 years of regulatory experience:
Syntex, Alza, Wyeth-Ayerst, Salix, Sugen
and numerous clients

 

Regulatory Affairs
certified (RAPS)
knowledge of FDA, HPB, UK, EU and
ICH regulations and guidelines

 

FDA/HPFB/MCA
experience

 

extensive experience writing documents
for regulatory submission
therapeutic area experience: antivirals, anti-infectives, dermatologicals,
cardiovascular agents, non-steroidal anti-inflammatories, pulmonary drugs,
drug/device combinations, gastrointestinal and endocrine products, 
controlled release delivery

Margie Nemcik-Cruz: mncruz@pacbell.net