Niranjan Khangate Email & Phone Number

Thane, Maharashtra, India

Pune, Maharashtra, India

Pune, Maharashtra, India

Thane, Maharashtra, India

Regulatory Start Up Department

Pune

Quality Check of site, country and core clinical documents i.e. from study start-up to study closure as per project specific metrics tool (e-TMF).• Safety documents: SUSAR, PSUR, CIOMS, Med Watch, SAE reporting forms.• Subject Specific: Inform Consent, Case Report Form, Subject Diaries, Source documents.• Regulatory: IND, NDA, MOH-APP, Import-Export Licenses and GMP Manufacturing Licenses etc, Regulatory submission checklist (E-DP), Clinical study report (CSR).• Product Specific: IMPD, COA, Bio analytical report, Accelerated stability study reports etc.• Site Specific: Form 1572, FDF, CV's, CTA, CDA, Site Monitoring Reports, ICF, IP Shipment and IP-Release etc.• Quality check/review for the indexed documents, Maintain error sheets, Track and compile all errors.• Correcting the filling location of indexed documents incorrectly filled in the repository and manage the augmentation process.• Regulatory team co-coordinator for regulatory documents and discrepancy management.• Review of regulatory documents, publishing and formatting the documents, checking orientation, split and combining documents as per regulatory requirement, update internal trackers.• Mentor of team for different activities in process.• Single point of contact: Prepare error logs share them with team to ensure accuracy is maintained, resolve queries of team, conduct update sessions, and provide support to management team.• Have worked in Pilot Projects.

Master Of Pharmacy In Pharmacology, B

Bachelor Of Pharmacy (B.Pharm.)

Activities and Societies: · I have attained National Conference on Pharmaceutical Industry Management “Pharma Pulse 2012”. · I have.

Education record

Secondary School Certification