Princeton Office
Princeton Office
Hyderabad Office
101 College Road East Princeton NJ 08540 USA
SBH Officers Colony, Mega Hills, Ayyappa Society, Madhapur
(040) 4503 8660
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
End to End Regulatory Solutions & Capabilities
TOTALRegulatory Services Overview
Regulatory Affairs Services
Regulatory Strategy
Regulatory Intelligence
Regulatory Submissions
Process Standardization
Labeling and Artwork
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 and Submission
Regulatory Dossier Gap Analysis (IND,NDA,BLA,ANDA,CTA,MAA, DMF)
Post-Approval Gap Analysis
Product Registrations
Labeling Services
Artwork & Labeling
SPL Conversions & RLD Updates
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 and Reassessments
Labeling Updates
Electronic Regulatory Dossiers
Change Control and 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
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
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