+91 - 8879610078 Info@scuberegulatoryservices.com

Welcome to  S-Cube Regulatory Services

Welcome to  S-Cube Regulatory Services

Your Trusted Partner in Regulatory Affairs & Compliance

At S-Cube Regulatory Services , we provide comprehensive regulatory consulting solutions for the pharmaceutical, medical device, cosmetic, nutraceutical, herbal, and biotechnology industries. Our experienced professionals assist businesses in navigating complex regulatory requirements, ensuring timely approvals while maintaining the highest standards of quality and compliance.

Establishing a Pharmaceutical or Medical devices manufacturing facility requires strict compliance with the regulations of the Central Drugs Standard Control Organization (CDSCO) and the Food Safety and Standards Authority of India (FSSAI). Our specialized consulting services ensure that facility designs and plant layouts conform to Schedule M for pharmaceutical manufacturing and Schedule IV of the Food Safety and Standards Regulations for medical facilities. We provide end-to-end support, from preparing regulatory documentation to obtaining manufacturing licenses and product approvals. In addition, we assist with Bureau of Indian Standards (BIS) compliance, environmental clearances, and other statutory requirements. Where applicable, we also ensure adherence to AYUSH guidelines and industry-specific quality standards. By integrating regulatory expertise with engineering excellence, we help manufacturers build compliant, efficient, and globally competitive facilities that uphold the highest quality standards and strengthen the reputation of "Made in India" products.





Our Expertise in Regulatory Affairs & Compliance

Shaping Today and The Future with
Our Services

Navigating today's highly regulated healthcare landscape requires far more than completing statutory formalities - it demands strategic regulatory expertise that transforms compliance into a sustainable business advantage. Our specialized Pharmaceutical and Nutraceutical Regulatory Consulting services accelerate market entry while establishing a robust framework for long-term operational excellence and global expansion. We seamlessly manage the complexities of CDSCO and FSSAI licensing, ensuring your manufacturing facilities, products, and quality systems fully comply with Schedule M, Good Manufacturing Practices (GMP), and all applicable regulatory requirements. By securing regulatory approvals efficiently and implementing compliance-driven processes from the outset, we help protect your organization from costly delays, regulatory risks, and operational disruptions while strengthening product quality, consumer confidence, and long-term market credibility.



Our Services

We provide end-to-end regulatory support from product development and documentation to submissions, approvals, and post-approval compliance allowing our Blog & FAQ to focus on innovation while we manage the regulatory process. Our expertise ensures smooth project execution from concept to commercialization while meeting all statutory requirements.

Our Services


Regulatory Affairs Consulting

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.


Product Registration

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.


Dossier 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.


CDSCO Regulatory Services

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.


Medical devices

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.


Nutraceutical & Food Supplements

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


GMP Compliance

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


Pharmacovigilance

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

Why Us?



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