Our Services
Regulatory Strategic Advisory Services
Project Feasibility Evaluation
Regulatory Intelligence
Developing Quality Target Product Profile
Assessment of Product Development Path
Regulatory Submission Strategy
Interaction with Health Authorities
Remediation of Regulatory Deficiencies & Observations,
Market Extension Strategies
Regulatory Due Diligence For Acquisition of Marketing Authorization
Regulatory Gap Analysis for Market Extension
Development Quality Assurance & Project Management Services
Designing QMS for R&D
Data Integrity Assessment
Audit and Compliance Assessment of CDMO for sponsors
Audit and Compliance Assessment of CDMO for sponsors
Conducting Stage Gate Review
QMS Document Management
Specialized Remediation of GxP issues
Regulatory Review Cycle Management
Drug Master Files
Country Specific Administrative Sections
CMC, Clinical & Non-Clinical documentation
Drafting deficiency responses
Expert review of submission files
Technical Information Exchange for Product Launch
Regulatory Submission Services
NeeS publication
eCTD publication
Legacy Submission Upgradation
Post Approval Change Management & Compliance
Change Control Management
Annual Reports
Renewals
Variation submissions
PADER and Safety Alerts
Artwork & Labeling Services
State of the Art Inhouse Studio
Artwork Preparation and Change Management
Artwork Proofreading and Quality Check
Global Labeling Management
Promotional Materials
Audit and Compliance Services
Vendor Qualification
GMP Third Party Audits
GMP Compliance Consulting
Biostudy Monitoring
Medico Pharmavigilence Services
Medical Information Management
Post Marketing Pharmacovigilance
Clinical Trail Safety Monitoring
PV Support
Data Analytics & Software Solutions
Data Analytics in Operations Management
Customized Software Solutions
Consulting Services in Data Mining Requirements
Merger & Acquisition Facilitation Services
Project Management
Due Diligence Reporting
Strategic Consulting
Regulatory Strategic Advisory Services
Project Feasibility Evaluation
Regulatory Intelligence
Developing Quality Target Product Profile
Assessment of Product Development Path
Regulatory Submission Strategy
Interaction with Health Authorities
Remediation of Regulatory Deficiencies & Observations,
Market Extension Strategies
Regulatory Due Diligence For Acquisition of Marketing Authorization
Regulatory Gap Analysis for Market Extension
Development Quality Assurance & Project Management Services
Designing QMS for R&D
Data Integrity Assessment
Audit and Compliance Assessment of CDMO for sponsors
Audit and Compliance Assessment of CDMO for sponsors
Conducting Stage Gate Review
QMS Document Management
Specialized Remediation of GxP issues
Regulatory Review Cycle Management
Drug Master Files
Country Specific Administrative Sections
CMC, Clinical & Non-Clinical documentation
Drafting deficiency responses
Expert review of submission files
Technical Information Exchange for Product Launch
Regulatory Submission Services
NeeS publication
eCTD publication
Legacy Submission Upgradation
Post Approval Change Management & Compliance
Change Control Management
Annual Reports
Renewals
Variation submissions
PADER and Safety Alerts
Artwork & Labeling Services
State of the Art Inhouse Studio
Artwork Preparation and Change Management
Artwork Proofreading and Quality Check
Global Labeling Management
Promotional Materials
Audit and Compliance Services
Vendor Qualification
GMP Third Party Audits
GMP Compliance Consulting
Biostudy Monitoring
Medico Pharmavigilence Services
Medical Information Management
Post Marketing Pharmacovigilance
Clinical Trail Safety Monitoring
PV Support
Data Analytics & Software Solutions
Data Analytics in Operations Management
Customized Software Solutions
Consulting Services in Data Mining Requirements
Merger & Acquisition Facilitation Services