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 Project Management Due Diligence Reporting Strategic Consulting