Self-motivated and hardworking full time freelancer actively doing technical writing projects with expertise in medical, biology, pharmaceutical and healthcare field.
Being a Master of Pharmacy (completed 4 year graduate + 2 year post graduate course in Pharmaceutical Science) having 15 years experience in Pharmaceutical Research with expertise in Natural Products, Dietary Supplement, OTC and Generic drugs for US/EUROPE. I can do Quality Research regarding any Medical-related topics from Primary, Secondary and Tertiary literature, and can also Summarize any Medical-related content of Scientific Document.
My technical expertise in field of Pharmaceutical Research is summarized as below:
? Clinical Trials data summary with respect to drug safety and efficacy studies
? Review of Bio study design and interpretation of results.
? Technical Document Writing:
SOP’s preparation,
Equipment qualification protocols preparation,
Technology transfer documents,
Formulation Development Report (Section 3.2 for Module 3: Quality)
Technology Transfer Document
? Review of Bio study design and interpretation of results.
? Preparation of Patent summary and development of Non-infringing Strategies for
formulation development
? Exposure to QbD in Pharmaceutical Development, Quality Risk Management and
Pharmaceutical quality system
? Understanding of International regulatory requirements such as USFDA, UKMHRA
? Documentation towards ANDA & dossier submission in QbD format
? Document preparation and regulatory queries handling to the satisfaction of approving authorities eg. USFDA, EMEA, UK-MHRA
? Formulation Development with expertise in Herbal, Monograph, Dietary Supplement, OTC and Generic drugs ANDAs/ NDA [505 (b)(2)] for US/EUROPE.
I will write top notch Research Projects in Pharmacy, Medical, Biology, and Healthcare.