- Project Management
- Due Diligence Reporting
- Strategic Consulting
- Vendor Qualification
- GMP Third Party Audits
- GMP Compliance Consulting
- Biostudy Monitoring
- Data Analytics in operations management
- Customized Software Solutions
- Consulting services in Data Mining Requirements
- State of the Art In-house Studio
- Artwork Preparation and Change management
- Artwork Proofreading and Quality Check
- Global Labelling Management
- Promotional Materials
- Medical Information management
- Post Marketing Pharmacovigilance
- Clinical trial Safety Monitoring
- PV Support
- NeeS Publication
- eCTD Publication
- Legacy Submission Upgradation
- Designing QMS for R&D
- Data Integrity Assessment
- Audit and Compliance Assessment of CDMO
- Audit and Compliance Assessment of CRO for sponsors
- Conducting Stage Gate Review QMS Document Management
- Specialized Remediation of GxP issues
- 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
- Change Control Management
- Annual Reports
- Renewals
- Variation submissions
- PADER and Safety Alerts
- Project Feasibility Evaluation
- Regulatory Intelligence
- Developing Quality Target Product Profile
- Assessment of Product
- Development Path
- Remediation of Regulatory Deficiencies & Observations
- Market Extension Strategies
- Regulatory Due Diligence For Acquisition of Marketing Authorization
- Regulatory Gap Analysis for Market Extension
- Interaction with Health Authorities
- Regulatory Submission Strategy
- Regulatory Strategy Development
- Pre-market Submissions
- Quality Management Systems (QMS)
- Post-market Surveillance
- Product Classification and Pathway Determination
- Investigational New Drug (IND) Applications
- Good Manufacturing Practice (GMP) Compliance
- Regulatory Liaison
- Comparative Analytical Studies
- Clinical Development Planning
- Regulatory Submissions
- Interchangeability Assessments
- Regulatory Pathway Navigation
- Clinical Trial Design and Oversight
- Risk Assessment and Mitigation
- Post-Approval Monitoring
