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Prudentia Consulting India Pvt. Ltd. - Service Provider of safety database configuration management services, reports development services & validation service in Noida, Uttar Pradesh.

Nature of Business

Service Provider

Legal Status of Firm

Limited Company (Ltd./Pvt.Ltd.)

Annual Turnover

Rs. 5 - 10 Crore

GST Number

09AAHCP3696F1Z0

Safety Database Configuration Management Services
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Prudentia provides experienced cost-effective configuration administration of drug safety systems including master data libraries such as:

1. Product Library
2. Protocol Library
3. User Maintenance
4. MedDRA Dictionary Management

Prudentia’s team provides configuration services 21×5 to support multiple time zones based on user requirements

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Reports Development Services
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Prudentia supports business end users to resolve data query needs by either front end reports or backend database extracts. Services include configuration of queries (private and public) to get desired data set, development of SQL queries for backend database extracts, development of custom reports using Business Intelligence tools such as Crystal Reports, Business Objects, Cognos or OBIEE, and validation of reports to confirm data accuracy and consistency. Prudentia’s analyst also support end users with identifying and defining custom report requirements.

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Validation Service
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Validation Service

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Prudentia produces validated computer system solutions. We do it for our systems and we do it for our clients’ systems. Our team of onshore and offshore resources can lead validation streams, author test scripts, dry run scripts, pre-approve scripts, execute scripts, and post-approve scripts.

Our team can also author validation plans, data migration plans, risk assessments, trace matrices, test plans, test summary reports, and validation summary reports. Our team is well versed in GAMP 5 processes supporting FDA CFR 21 Part 11 and EU Annex 11.

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Submission Rules Maintenance Service
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Prudentia's business and validation analysts support large and medium sized companies with maintaining the submission rules library in the safety database. Services include managing user requirements document in collaboration with local safety affiliates, managing scheduled reviews with regulatory responsibles, supporting the development activities, configuring the submission rules in the application and testing the rules to ensure compliance with regulatory requirement.

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E2B R3 Conversion Service
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Prudentia supports companies without E2B R3 compliant safety databases with conversion services which include business analysts performing daily EudraVigilance searches for company’s ICSRs to be downloaded (e.g., MLM and NCA cases), converting the downloaded E2B R3 ICSRs into a compliant E2B R2 file using Prudentia’s E2B BRIDGE conversion application, maintaining a daily tracking sheet of ICSRs downloaded and converted, and optionally importing the E2B R2 file into the company’s safety database.

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Data Entry Service

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Prudentia’s team of medical coders are experienced in medical coding and are knowledgeable in GCP and related regulations. They have a strong and in-depth knowledge of MedDRA and WHO Drug dictionaries and can provide coding of adverse events, medical history, indications, labs, suspect and concomitant products as per industry standards including management of synonym lists.

Our medical coders are expert in the new Who Drug B3 / C3 format and can help you migrate your coded data to the newer format.

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Prudentia Consulting India Pvt. Ltd.Office No. 11, 6 Floor, Stellar It Park, T25, Sector 62, Near Jss Coolage, Noida, Gautam Budh Nagar-201309, Uttar Pradesh, India

Neeraj (Owner)

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