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Prakash Renga
Deputy General Manager-Quality &Compliance at Scitus Pharma Services
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Work Experience
Feb 2022 - Present · 2 years and 11 months
Deputy General Manager-Quality &Compliance
Apr 2023 - Present · 1 years and 9 months
Associate General Manager -Quality & Compliance
Feb 2022 - Mar 2023 · 1 years and 1 months
Manager- Gcp Quality Assurance
Apr 2019 - Feb 2022 · 2 years and 10 months
Company Details
201-500 Employees
Scitus Pharma Services Private Limited is an US FDA approved organization capable of providing clinical research services to the pharmaceutical and biopharmaceutical industries. We have the world-class infrastructure for Clinical Pharmacology units with 110+ beds and 12+ LC-MS/MS for ensuring the timely submission of your projects. In addition to BA/BE experience, we have a group of highly skilled clinical research professionals to conduct Clinical Bioequivalence studies and Phase II to IV clinical trials, Clinical Data Management in India. We also support the life cycle management of generic drug products of pharmaceutical companies by providing comprehensive pharmacovigilance solution that starts with Medical Information Call Center to the submission of aggregate reports and also include risk assessment and signal detection. Currently we are covering about 40 drug products for US FDA submission and are hoping to reach 100+ drug products by the end of this year. We have a team of experts with long years of experience in providing pharmacovigilance services to the US markets and are committed to helping small and medium sized pharmaceutical companies meet and exceed the challenging demands of the lifecycle management of drugs.
Year Founded
2017
Social Media
Linkedin
Industry
Pharmaceutical Manufacturing
HQ Location
II floor, SIDCO Multi-storied Complex SIDCO Industrial Estate Thirumazhisai, Chennai, Tamil Nadu 600124, IN
Keywords
CROBA/BE studiesPharmacovigilanceClinical Trialsand CDM
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