Ajit Walke
Assistant Manager at Raptim Research Pvt. Ltd
Based in Pune, India
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Seniority
Manager
Department
Manufacturing & Production
Location
Pune
Industry
Pharmaceutical Manufacturing
Company size
510
Contact information
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a•••••••@raptimresearch.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Ajit Walke
Preparation and review of clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study report (CSR), Investigator Brochure (IB) and eCTD modules ( 2.5 & 2.7) across therapeutic areas. Quality check of clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study report (CSR), Investigator Brochure (IB) and eCTD modules ( 2.5 & 2.7) across therapeutic areas. Team Handling. CRO selection and monitoring. Initiate a startup meeting with a study team related to creation and development of clinical documents for regulatory submissions. Share the timelines among the study team for development of regulatory documents. Filling and documenation of various kinds of NOCs, Import and export licences for IMP, Study reports and amendment to DCGI and West zone. Preparation and Review of informed consent (ICD) in english. Preparation and review of Standard Operating Documents (SOP).
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