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Techsol Life Sciences
Techsol Life Sciences
 
 
  • CLINICAL
    • Clinical Development Services
      • Scientific And Medical Writing
      • Clinical Operations & Study Monitoring
      • Clinical Data Management
      • Biostatistics & SAS Programming
      • Regulatory Affairs
      • Drug Safety And Pharmacovigilance
      • Regulatory Lifecycle Management
      • Launch & Commercialization
      • Data Safety Monitoring Board
      • Medical Monitoring & Review
    • Clinical Study Expertise
      • Therapeutic Areas
      • Early Phase Studies
      • Observational Studies
      • Investigator Initiated Studies
      • Real World Evidence
      • Post-Marketing Clinical Follow-Up
      • Registry Trials
      • Patient Surveys
      • Food & Nutraceuticals
    • Clinical Technology Services
      • AccelClinical
      • Oracle Clinical One
      • AccelStudy
      • EPRO & ECOA
      • CTMS & Site Payments
      • Electronic Trial Master File
      • Clinical Oversight Platform
  • REGULATORY
    • Regulatory Capabilities Overview
      • Full Scale Regulatory Solutions & Capabilities
      • TOTALRegulatory Services Overview
    • Regulatory Affairs Services
      • Regulatory Strategy
      • Regulatory Intelligence
      • Regulatory Submissions
      • Process Standardization
      • Labeling & Artwork Compliance
      • HA Interactions & Country Support
      • Regulatory QMS & Audit Support
      • Pre-Submission Meetings: IND
      • Pre-Submission Meetings: NDA
      • Pre-Submission Meetings: BLA
    • Regulatory Operations Services
      • eCTD Publishing & Submission
      • Regulatory Dossier Gap Analysis (IND,NDA,BLA,ANDA,CTA,MAA, DMF)
      • Post-Approval Gap Analysis
      • Product Registrations
      • Artwork & Labeling
      • SPL Conversions
      • RLD updates & Labeling Services
      • QRD Preparation-EMA
      • SmPC & ePI
      • Local Labeling & Translations
      • Labeling Compliance & Advisory
      • REMS & RMP Plans
    • Life Cycle Management Services
      • Post-approval supplements US FDA
      • Variations EU
      • Renewals & Reassessments
      • Labeling Updates
      • Electronic Regulatory Dossiers
      • Change Control & Regulatory Impact Assessments
      • Global Market Expansion
      • Electronic Documents & Data
      • Biosimilars & Biologics
    • Specialized & Niche Services
      • Gene Therapy & Novel Treatments
      • MoCRA US FDA Services
    • Content Authoring Services
      • Regulatory Briefing Documents
      • CMC Content Authoring
      • Non-Clinical Content Authoring
      • Clinical Content Authoring
  • PHARMACOVIGILANCE
    • PV Capabilities Overview
      • Overview of All Pharmacovigilance Products & Services
      • Pharmacovigilance Technology Solutions
      • Pharmacovigilance Operations Oversight & Agentic AI Solutions
      • Integrated & Automated Functional Services
    • PV Technology Solutions
      • Oracle Argus Safety One Cloud
      • Oracle Empirica Signal Cloud
      • AccelSafety-Argus & Empirica
      • Axway E-Submission Gateway
      • Safety System Service Desk (SSD)
      • Safety Data & Systems Migration
      • Safety Integration Services
      • Safety Analytics & Reporting
    • PV Oversight & Agentic AI
      • Compier PV Ops & Agentic AI
      • Intake – Inbox & Correspondence
      • Intake – Literature Screening
      • Intake – Agency Intake
      • ICSR Tracking & QA
      • Aggregate Reports
      • Agreements & Reconciliation
      • PV Systems Master File
    • PV Functional Services
      • TOTALVigilance Services
      • Case Processing Services
      • Aggregate Safety Reports
      • Literature Monitoring Services
      • Safety Signal Management
      • QPPV & LPPV Services
      • PSMF Lifecycle Management
      • PV Risk Management Services
      • Med Info Contact Center
      • Materiovigilance Services
      • PV Audits & Training Services
      • PV Regulatory Intelligence Services
  • QUALITY & LABS
    • Quality Management System
      • TrackWise Implementation & Validation
      • TrackWise System Integrations
      • TrackWise EQMS Application Support
      • Quality Insights Generation
    • Quality & Labs Image
  • MEDTECH
    • Medical Writing & Clinical Affairs
      • Clinical Affairs Strategy
      • Medical Device Registration
      • MedTech Medical Writing
      • Clinical Investigation & Evaluation
      • Technical Files & Dossier Preparation
      • Device Approval Submissions Support
    • Device Vigilance & Reporting
      • Safety Data Management
      • Medical Device Reporting (MDR)
      • Post-marketing Surveillance Support
      • PSUR Submissions
      • Literature Search and Review
      • EU PMS – FSCA Reporting
    • Regulatory Affairs & Labeling
      • Regulatory Lifecycle Management
      • EU MDR / IVDR Consulting
      • Product Certification: CE Marking
      • Medical Device Labeling
      • Post-Market & Regulatory Support
      • Medical Device Artwork Management
  • CAPABILITIES
    • Pharma Digital Transformation
      • Strategic Technology Consulting
      • Validation & Assurance Services
      • System Integration Services
      • Data Science & Artificial Intelligence
      • Intelligent Process Automation
      • Custom Applications Development
      • Data Standards Consulting
      • Teaming Partner Services
    • Clinical And Data Services
      • Early Phase Clinical Trials
      • Phase II – III Clinical Research
      • Phase IV & Real-World Evidence
      • Medical Device Solutions
    • Technology Platforms
      • AccelSafety
      • AccelCTMS
      • Compier PV Ops
      • SciMax Medical Information
      • SciMax Publications
      • SCIMAX Collaboration Portal
      • SCIMAX IIT Portal
      • SCIMAX EAP Portal
      • SCIMAX Grants Portal
  • ABOUT
    • About US
    • Techsol Life Sciences
      • Company Overview
      • Quality Accreditations
      • Meet Our Team
      • Our History
      • Industry Partners
      • Awards & Recognition
      • Careers
      • Contact Us
    • Resource Library
      • Case Studies
      • Insights
      • Events
      • Press Releases
  • Specialized Regulatory Writing Solutions for Clinical Overviews in Combination Therapy Submissions
    May 1, 2025
  • Over coming challenges in drafting region-specific clinical summaries
    April 14, 2025
  • Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study
    December 29, 2022
  • Hugel Logo | Techsol Life Sciences
    Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma
    December 29, 2022
  • IPCA
    Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution
    December 29, 2022
  • Gemvax & KAEL | Techsol Life Sciences
    Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax
    December 27, 2022
Categories
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  • Company Updates
  • CTMS
  • Drug Safety
  • Innovation
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  • Uncategorized
  • Validation & Assurance
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Techsol Life Sciences
  • Techsol Life Sciences, 101 College Road East, Princeton, New Jersey, 08540, USA
  • Techsol Life Sciences Private Limited, Plot No: 845, Road No: 45, SBH Officers Colony, Mega Hills, Ayyappa Society, Madhapur, Hyderabad, Telangana 500081
  • 040-45038660

Featured Solutions

  • Medical Writing
  • Clinical Operations
  • Clinical Data Management
  • Pharmacovigilance
  • Regulatory Affairs
  • Compier
  • SciMax
  • AccelSafety
  • AccelCTMS
  • AccelStudy

Recent Posts

  • Understanding the Importance of CMC (Chemistry, Manufacturing, and Controls) documents in the Pharmaceutical Product Lifecycle April 8, 2024
  • MoCRA Made Easy: A Comprehensive Guide to Cosmetic Safety Compliance January 29, 2024
  • Understanding how Disease Registries can Power Oncology R&D Pipeline and De-Risk Clinical Trials January 24, 2024
  • Mastering Medical Device Registrations: A Guide to Navigating Regulatory Pathways July 12, 2023

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