Welcome to  S-Cube Regulatory Services

We assist in obtaining and renewing licenses from key regulatory bodies such as Drug manufacturing licenses, Nutraceutical/Food licenses, Import-export licenses, State and central regulatory approvals & all types of regulatory affairs for pharmaceutical, nutraceutical, and healthcare.

We Provide complete Product Registration from Greenfield & brownfield project planning to Documentation & SOP preparation. Facility design (GMP), Installation, Operational, Performance Qualification to Process & cleaning validation, Documentation & SOP preparation.

We Provide complete support for Dossier Preparation to Prepare accurate, submission-ready regulatory dossiers for CDSCO and global authorities, including CTD/eCTD documentation, technical data, quality information, and compliance records to accelerate product approvals.

We Provide Comprehensive CDSCO regulatory services covering product registration, manufacturing licenses, import approvals, documentation, compliance, submissions, and regulatory liaison support as per regulatory compliance under CDSCO guidelines.

We Provide complete end to end support for procuring Medical devices required for setup. We also do SOP preparation. Facility design, Installation, Operational, Performance Qualification to Process & cleaning validation, Documentation for medical devices.

We Provide Expert regulatory consulting for nutraceuticals and food supplements, including FSSAI licensing, product compliance, formulation review, labeling, documentation, and market approval support.

We Provide Comprehensive GMP compliance consulting including gap assessments, quality systems, SOP development, documentation, training, audit readiness, and regulatory compliance for pharmaceutical manufacturing facilities.

We provide Comprehensive pharmacovigilance services including adverse event reporting, signal detection, risk management, regulatory compliance, safety monitoring, periodic safety reports, and global pharmacovigilance support.