Madhukiran Parvathaneni, PhD
Manager Global Regulatory Affairs at CRC Pharma- Claim this Profile
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Bio
Ross W. McQuivey, M.D.
As the Chief Medical Officer of Clinical Innovations, a mid-size global medical device company, I have had the pleasure to work with Madhukiran as a consultant the past year. Madhukiran's knowledge, support and positive attitude is second to none. He continues to provide outstanding regulatory and leadership support to us during a time of remediation. He is very collaborative and efficient with his deliverables and is an excellent communicator. I would recommend Madhukiran without hesitation. Ross W. McQuivey, M.D.
Samantha Bernard
Incredibly knowledgeable and steadfast are the first words that come to mind to describe Dr. Parvathaneni's character. I had the pleasure of being taught pharmacology, drug design and development, computer-aided drug design and collaborating on a successful publication with Dr. Parvathaneni. I was impressed with his dedication to student success, and I was always interested in his insights on molding our futures. It would be advantageous for any student to have Dr. Parvathaneni as a professor.
Ross W. McQuivey, M.D.
As the Chief Medical Officer of Clinical Innovations, a mid-size global medical device company, I have had the pleasure to work with Madhukiran as a consultant the past year. Madhukiran's knowledge, support and positive attitude is second to none. He continues to provide outstanding regulatory and leadership support to us during a time of remediation. He is very collaborative and efficient with his deliverables and is an excellent communicator. I would recommend Madhukiran without hesitation. Ross W. McQuivey, M.D.
Samantha Bernard
Incredibly knowledgeable and steadfast are the first words that come to mind to describe Dr. Parvathaneni's character. I had the pleasure of being taught pharmacology, drug design and development, computer-aided drug design and collaborating on a successful publication with Dr. Parvathaneni. I was impressed with his dedication to student success, and I was always interested in his insights on molding our futures. It would be advantageous for any student to have Dr. Parvathaneni as a professor.
Ross W. McQuivey, M.D.
As the Chief Medical Officer of Clinical Innovations, a mid-size global medical device company, I have had the pleasure to work with Madhukiran as a consultant the past year. Madhukiran's knowledge, support and positive attitude is second to none. He continues to provide outstanding regulatory and leadership support to us during a time of remediation. He is very collaborative and efficient with his deliverables and is an excellent communicator. I would recommend Madhukiran without hesitation. Ross W. McQuivey, M.D.
Samantha Bernard
Incredibly knowledgeable and steadfast are the first words that come to mind to describe Dr. Parvathaneni's character. I had the pleasure of being taught pharmacology, drug design and development, computer-aided drug design and collaborating on a successful publication with Dr. Parvathaneni. I was impressed with his dedication to student success, and I was always interested in his insights on molding our futures. It would be advantageous for any student to have Dr. Parvathaneni as a professor.
Ross W. McQuivey, M.D.
As the Chief Medical Officer of Clinical Innovations, a mid-size global medical device company, I have had the pleasure to work with Madhukiran as a consultant the past year. Madhukiran's knowledge, support and positive attitude is second to none. He continues to provide outstanding regulatory and leadership support to us during a time of remediation. He is very collaborative and efficient with his deliverables and is an excellent communicator. I would recommend Madhukiran without hesitation. Ross W. McQuivey, M.D.
Samantha Bernard
Incredibly knowledgeable and steadfast are the first words that come to mind to describe Dr. Parvathaneni's character. I had the pleasure of being taught pharmacology, drug design and development, computer-aided drug design and collaborating on a successful publication with Dr. Parvathaneni. I was impressed with his dedication to student success, and I was always interested in his insights on molding our futures. It would be advantageous for any student to have Dr. Parvathaneni as a professor.
Credentials
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Member
American Cancer SocietyJan, 2017- Nov, 2024 -
Full Member - Sigma Xi
Sigma Xi, The Scientific Research Honor SocietySep, 2016- Nov, 2024 -
Registered Pharmacist
Pharmacy Council of IndiaMay, 2008- Nov, 2024 -
ACS Member
American Chemical Society - San Diego Section -
Member, American Association for the Advancement of Science.
AAAS
Experience
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CRC Pharma
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Manager Global Regulatory Affairs
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Jun 2022 - Present
• Responsible for design, execution and reporting of Phase I-IV clinical studies for innovator oncology drugs, right from protocol design, data analysis, clinical study reporting as per the local regulatory requirements. • Responsible for advising project teams on subjects such as premarket regulatory requirements, export and labeling requirements, clinical study compliance issues, mentoring the scientific aspects of the study to appropriate Clinical Pharmacology representatives, analyzing clinical trial data, drafting Clinical Study reports, answering scientific & medical queries from IRB, IEC and health authorities. • Development, communication, implementation, and maintenance of global regulatory policies and strategic plans for drugs, medical devices and drug-device combination products. •Responsible for Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Annual Reports and Periodic Adverse Drug Experience reports submissions to the FDA to support development programs and clients marketed products. •Experience in new product registrations, variations, and renewals for medical devices with US FDA - [510(k) & PMA], EU - Tech Files, Clinical Evaluation reports (CER), Post Market Surveillance (PMS) reports and combination products. •Review and interpret regulatory rules as they relate to company products and procedures, research and development, clinical studies, testing, or records keeping and ensure that they are communicated through company policies and procedures. • Liaison between Company and Regulatory Authorities such as the FDA, EMA, competent authorities and notified bodies. •Prepare, review and approval of regulatory submission related information and documents from pre-clinical, clinical research, development, Drug Safety, Medical Affairs, Regulatory Affairs, Labelling and Manufacturing to ensure consistency with regulatory submissions and compliance with applicable regulations.
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Harrisburg University of Science and Technology
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United States
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Higher Education
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300 - 400 Employee
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Professor (Corporate Faculty), Biotechnology
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Aug 2022 - Present
Teaching Coursework for Master's & Bachelor's degree students: 1. Fall 2022 semester: Regulatory Affairs in Life Sciences Industry. 2. Spring 2018 semester : Pharmacology, Drug Design & Development and Computer aided Drug Design. 3. Spring 2017 semester : Pharmacology, Drug Design & Development and Computer aided Drug Design. Teaching Coursework for Master's & Bachelor's degree students: 1. Fall 2022 semester: Regulatory Affairs in Life Sciences Industry. 2. Spring 2018 semester : Pharmacology, Drug Design & Development and Computer aided Drug Design. 3. Spring 2017 semester : Pharmacology, Drug Design & Development and Computer aided Drug Design.
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Stark Associates LLC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Manager
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Apr 2021 - Nov 2021
•Experience in new product registrations for Medical Devices with US FDA [510(k) & PMA], EU and other countries.•Collect, review, and edit Post Market Surveillance data for PMS, PMCF and Clinical Evaluation Reports (CER) for Medical Devices.•Generate plans and reports to ensure compliance with evolving regulations.•Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.•Perform the development, review and approval of company Standard Operating Procedures (SOP), Work Instructions (WI) and policies.
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Client Service Representative (Regulatory Affairs)
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Apr 2017 - Mar 2021
•Establish and maintain strong internal cross-functional business linkages, especially with Clinical Research, Regulatory Affairs, Medical Affairs, Drug Safety, Quality and Resourcing.•Represent Stark Associates at Regulatory and Clinical Research groups at public forums and sponsored conferences as both delegate and primarily presenter.•Implement FDA regulated biotechnology or pharmaceutical requirements including FDA 21 CFR Parts 11, 820, GCP, ICH, HIPPA and Regulatory standards.•Understand industry and client requirements, gain comprehensive knowledge of company's services and solutions as well deep industry understanding to provide consultative solutions to clients.•Serve as the Pharma Industry expert – visit client sites/ give online presentations/ do email campaign to educate clients on the long-term value and measurable results using Stark Associates expertise in the areas of Clinical Research, Regulatory, Drug Safety, Quality and Validation.•Negotiate terms and support execution of Confidentiality Agreements (CDA), Request for Information (RFI), Request for Proposal (RFP), Master Services Agreements (MSA) and Statement of work (SOW) agreements with clients and vendors.•Oversee employee performance, conduct timely reviews and performance appraisals of the employees deployed at the Pharmaceutical, Biotechnology and CRO client places. •Perform audit preparation activities, support the conduction of internal and external audits.•Contribute to the study conduct, clinical data review, safety data evaluation and signal detection; support the preparation and deliver reports for study team on important aspects of the clinical study protocol (i.e. important endpoints, safety review).•Monitoring compliance and additional quality metrics, manage data, maintain standard guidelines for regulatory documentation operations and assisted in gathering relevant information to help contribute to client’s regulatory submissions (IND, NDA & ANDA).
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Jeevan Scientific Technology Limited
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India
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Research Services
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100 - 200 Employee
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Senior Regulatory Associate
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Jul 2015 - Dec 2015
• Development and review of regulatory dossiers modules (2.4, 2.5, 4 & 5) of Pre-clinical and Clinical study overviews, summaries, and reports for submission to the Healthcare Authorities in accordance with their respective guidelines and regulations. •Responsible for drafting, approval, and life cycle management of post-market surveillance documents like Clinical Evaluation Report (CER), Post-Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Post-Market Clinical Follow-up (PMCF) Plans and (PMCFER) evaluation reports. •Responsible for new and sustaining products regulatory filings, 510(K), PMA and annual reports to USFDA. Global Regulatory Submissions of for class I, II A/B & III Medical Devices for Canada, Japan, China, EU, and MDSAP Countries. •Regulatory assessment for labeling, design and/or manufacturing change and its impact. Preparation and review of regulatory Labeling Documents such as Information for use (IFU), Artwork Labels, Unique Device Identifier (UDI) barcode Implementation on Labels and doing FDA – GUDID Submissions. •Responsible for establishing and maintaining strong internal cross-functional business linkages, especially with Clinical Research, Regulatory Affairs, Medical Affairs, Post Market Surveillance, Quality and Resourcing in Drugs, and Medical Devices. •Responsible for working with New Product Development models, Drug-Device Combinations, •Health Hazard Evaluations (HHES), Failure Mode Effective Analysis (FMEAS), Corrective and Preventive Action (CAPA), Risk Management and Design Changes from regulatory standpoint. •Responsible for evaluating key performance indicators of other employees and guiding them on areas of improvement. Representing the company at regulatory, medical writing, drug safety, and clinical research groups, forums and conferences.
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Freyr Solutions
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United States
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IT Services and IT Consulting
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700 & Above Employee
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Regulatory Affairs Associate
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Jul 2014 - Jun 2015
•Performed literature review for identification of product complaints and/or adverse events (AEs) and submission of Medical Device Reports (MDRs) to the FDA. •Authored Clinical Evaluation Reports. •Implementation of Unique Device Identifier (UDI) to medical devices in accordance with Global Unique Device Identifier Database (GUDID) business rules. Identification, collection and collation of certain device data attributes and their submission to GUDID. Includes tagging of medical devices with unique identifier which is alphanumeric. •Drafting and Quality check of PBRERs, clinical documents for submission to regulatory authorities, including investigator brochures, Clinical and non-Clinical overviews. •Responsible for tracking and Memo to file, and EU Notified Body product update notifications, involved in Clinical reports reviews, design dossier, other 510k documentation, and coordinate audit projects with internal and contractors.
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Andhra University
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Higher Education
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700 & Above Employee
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Senior Research Fellow
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Mar 2011 - Sep 2012
Worked as Senior Research Fellow (SRF) in a consortium entitled " UTILIZATION OF WEED FLORA OF MEDICINAL VALUE IN SOME IMPORTANT CROPPING SYSTEMS OF ANDHRA PRADESH" funded by World bank and Indian Council for Agricultural Research (ICAR) - National Agricultural Innovative Project (NAIP) Worked as Senior Research Fellow (SRF) in a consortium entitled " UTILIZATION OF WEED FLORA OF MEDICINAL VALUE IN SOME IMPORTANT CROPPING SYSTEMS OF ANDHRA PRADESH" funded by World bank and Indian Council for Agricultural Research (ICAR) - National Agricultural Innovative Project (NAIP)
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Education
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2010 - 2013
Andhra University
PhD, Pharmaceutical Sciences -
2016 - 2017
Harrisburg University of Science and Technology
MS Project Management -
2008 - 2010
Andhra University
Master's degree, Pharmaceutical Sciences -
2004 - 2008
Acharya Nagarjuna University
Bachelor's degree, Pharmacy
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