Documente Academic
Documente Profesional
Documente Cultură
www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Timeline
Established as Global Expanded to a full Incorporation of
Management Consulting, service Clinical ENHOPS Solutions Pvt.
Technology Services and Research Organization Ltd, a 100% subsidiary
Outsourcing company of Jeevan Scientific
www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Jeevan Scientific
www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Advantage with Jeevan Scientific
www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Services Range
PK PD Trials
Proof of concept, Safety & Efficacy Trails
BA/BE Studies
PMS, OS
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Services
www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
Clinical Operations
Experience in execution of more than 500 clinical trials for different regulatory
authorities
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Bio-analytical Research
Experience
Bioanalytical
Over 20 years of industrial experience
Subject sample analysis Provide complete range of analytical solutions
Method Development from Lead optimization to Clinical development
Method Validation Equipped with advanced bio-analytical
Tech transfer instruments and an efficient work force.
Experience in handling nearly 300 methods.
Facilities
Provisions for handling of both normal and light sensitive molecules
New Method development and validation is continuous process
Method validations as applicable regulatory guidelines and all processes as
per GLP
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Regulatory Affairs
Regulatory Affairs
Regulatory Affairs Compile Dossiers for New Product Launch
Post Approval Changes, Gap Analysis and HA Responses
Regulatory Affairs
Bibliographic and Line Extension Applications
Regulatory strategy and
Intelligence CMC Change Controls and Variations
Regulatory Writing Clinical Trial Application Dossiers
Regulatory Operations
Regulatory Labeling Regulatory Writing
Reg. business and Clinical Study Synopsis, Protocols and Amendments
Outsourcing consultancy Investigator Brochures, Informed Consent Documents
Clinical Study Reports (CSRs); Phases I to IV and BA/BE
Clinical Trial Registries and Results Disclosure
Drug Master File (DMF) & Investigational Medicinal Product
Dossier (IMPD)
Safety and Patient Narrative Writing
SAE reports for Health Authorities and IRBs Submission
Regulatory Operations
Publishing Services (eCTD, NeeS, Paper)
SPL Submission Services
Artwork Services
Product Lifecycle Management
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Regulatory Affairs
Regulatory Affairs Strategy and Intelligence
Regulatory Strategic Planning for New Product Development and Launch
Regulatory Affairs New Market Regulatory Strategy Intelligence
Regulatory strategy and Specialized Strategic Planning for Fast Tracked and Orphan Products
Intelligence
Access, Summarize and Assess Global Regulatory Intelligence
Regulatory Writing
Regulatory Operations Labelling
Regulatory Labeling
Company Core Data Sheet (CCDS)
Reg. business and
Outsourcing consultancy Local Product Labels
Summary of Product Characteristics (SmPC)
Patient Leaflets, Inner and Outer Package Labels
Product Information File (PIF), SPL creation
Supporting Documentation (Clinical and Non-clinical Overviews)
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Medical Writing
Commercialization Writing Medical Writing
Medical Writing Manuscripts Consensus guidelines/
Book chapters statements
Commercialization Continuing Medical Education
Review articles
Writing (CME) slide sets
Monographs
Medical Writing Compendiums
Abstracts
Technical Writing Pre/Post conference reports
Posters
Customized Writing Patient educational material
Short summary of manuscripts
Slide sets
News letters
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Medical Writing
56 54
45
27 27
17 19
16 14
8 8
5 2 2 3 1
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Medical Writing Therapeutic Experience
Orthopedics
5% 5% 5% 5%
Nutrition Gastroenterology Health
Women's Health
Outcomes
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Clinical Data Management (CDM)
CDM
Data management
Biostatistics and
statistical programming
services
CRF/e-CRF Designing Double data entry and QC and database audits Interim database
Data Management Plan verification Adverse events closure
Database design and Set- Data Loading Evaluation of medical QA, QC Audits
up Data review and query and scientific consistency Database lock
Import/Export setup management of data Analysis and report
Dictionary set up SAE reconciliation Periodic review for
(MEDRA) Clinical data coding protocol adherence, data
CRF Tracking setup entry and regulatory file
maintenance
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Clinical Data Management (CDM)
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Pharmacovigilance
Pharmacovigilance
Case processing
Aggregate reports
Signal detection and Risk
management plans
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Why Jeevan ???
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Contact Us
For Business :
Mr. Vasudev Sureddy
: +91 40-30912999
: +91-76590 11000
: vasudev.sureddy@jeevanscientific.com
: info@jeevanscientific.com
Address:
Jeevan Scientific Technology Limited
Plot No. 1&2, Sai Krupa Enclave
Near Lanco Hills, Golconda post
Hyderabad - 500 008
Telangana., India.
www.jeevanscientific.com Clinical Operations| Bioanalytical |Regulatory Affairs| Medical writing | Pharmacovigilance | CDM
THANK YOU
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