IdentityI am m. Pharm (quality assurance & regulatory affairs) I am giving online tutor since I am experience for b. Pharm & d. Pharm students teaching and regulatory affairs officer experience in company work and I'm certified in pharmacist. I ga a degree in m. Pharm quality assurance. My key skills are • conversant with ich & fda guidelines, regulation and applicable global and local
Standard operating procedures.
• well-versed with schedule y, cgmp, nda, nda regulations, classification of drugs in
Nda
• pharmacokinetics, bioavailability, concept related to ba/be studies
• concept related to inda, anda, anda filing guidelines, para I-iv filing.
• awareness of international regulatory authorities and filing, hatch waxman act, orange
Book.
• knowledge of ipr, patent search, patent management.
• drug development processes :
Well versed in drug development processes (pre-clinical and clinical trial, ind and
Nda, icmr, ich guidelines, gcp requirement, protocol writing and informed
Consent).
O knowledge of notice to applicant for dossier writing.
• knowledge of us dmf (drug master file)
• knowledge of edmfs (european drug master file).
• knowledge of ipr, patent search, patent management.
Technical profile:
• lab spray dryer (labultima) •ultraviolet spectrophotometer (shimadzu)
• tablet compression machine •friability test apparatus
Dissolution apparatus • autoclave
Disintegration test apparatus. Any other relevant details to make your profile look richer.
