Regulatory affairs (RA) is a profession that ensures organizations comply with regulations.
RA professionals work in regulated industries such as pharmaceuticals, medical devices …

A new stability indicating reverse phase HPLC method has been developed and validated
as per International Conference on Harmonization guidelines for the determination of …

A simple, sensitive, and stability indicating isocratic reverse phase high performance liquid
chromatography method has been developed, optimized and validated for the separation …

The purpose of the present review is to summarize the current pediatric regulatory
requirements and also the regulatory efforts that need to be taken for the potential benefits of …

137 A TALE OF THREE REGIONS: QUALITY CULTURE AND ITS IMPACT ON
PHARMACEUTICAL PRODUCTION B. Swartz1* & S. Singh2 ARTICLE INF Page 1 South …

Regulatory authorities and organizations play a crucial part in responding to the
requirements of regulatory proceedings related to drug development in a region. Each …

A simple and sensitive stability‐indicating chiral HPLC method has been developed and
validated per International Conference on Harmonization guidelines for the determination of …

REVIEW ON INDIAN REGULATORY REQUIREMENTS OF CLINICAL TRIALS ON COVID
VACCINES Page 1 Karra et al., J Adv Sci Res, 2023; 14 (06): 19-29 19 Journal of Advanced …

The drug approval process is country-specific. The regulatory framework of all the national
regulatory agencies differ from one another in terms of administration and product specific …

Analytical and clinical uses, as well as the assessment of pharmacological or hazardous
effects on human health, depend critically on the isolation and identification of specific …