Dr. Neha Singh

Seasoned Regulatory Officer with total of 13 year's experience with almost 6 years in Regulatory Affairs. Ph.D. in Chemistry with 8 years of research experience. Published many research papers in renowned Scientific Journals. Currently, working as a Regulatory Specialist in Medical Electronics Business Unit @Tata Elxsi, where I am taking up RA activities like creation of Technical documentation (STED), Doc, GSPR, Clinical documents like CEP, CER and Post Market Clinical Follow up Evaluation Report (PMCFER) for EUMDR compliance of Medical Devices. Earlier was working in the capacity of Research Scientist in Medical Device division at CDSCO ,DGHS,MOHFW, Delhi in Medical Device division. Involved with-

• Undertaking technical assessment for Medical Devices & Diagnostics.

• Providing technical assistance towards identification and regulation of medical devices & diagnostics

• Analysis of data/market research on quality assessments of medical devices.

• Resolving Queries and Clarification of Medical Device Industries. 

• Strong Knowledge and experience of EU MDR 2017/745 / EU MDD 93/42/EEC and standards like ISO 13485:2016, ISO 14971 etc.

• Review of applications for issuing of import, manufacturing and test licenses on SUGAM portal.

• Screening and reviewing of CTD (Common Technical Document) dossiers, Test reports, stability data, etc. pertaining to Registration, Import License, approval of Manufacturing license as per Drugs and Cosmetics Act & Rules,1945 thereunder.

• Review of Non-clinical & Clinical data, SAE reports, PMS data, Clinical Trial Protocol, Case Report form (CRF), Informed Consent documents for regulatory compliance.

Expertise in Quality Control Testing in Pharmaceutical and Phytopharmaceutical Industry using HPLC,GC,HPTLC,NMR,IR analytical techniques. Drafted Monographs and General Chapters of Indian Pharmacopoeia(IP) and NFI.

Skilled in analytical research and scientific publication writing. Comprehensive clinical awareness. Thorough understanding of the medical field. Strong flair and passion for writing and networking. Strong written and verbal communication/presentation skills. In addition. having 2 years of exposure in CTR and regulatory dossier filing.

My areas of interest are-Regulatory Affairs-Medical Devices, QMS, Medical Writing.