Service Details

1.CDSCO & DHR Registration

CDSCO & DHR Registration services ensure regulatory compliance for clinical research, Ethics Committees, and healthcare-related activities in India. We provide end-to-end support including documentation, application submission, regulatory coordination, compliance guidance, and renewal assistance to simplify the registration process efficiently and professionally.

2.Ethics Committee Setup

Ethics Committee Setup services include complete assistance in establishing and managing Ethics Committees as per regulatory guidelines. We support committee formation, SOP preparation, member documentation, regulatory compliance, CDSCO & DHR registration, and operational guidance to ensure a smooth and compliant setup process.

3.NABH & NABL Registration

NABH & NABL Registration services provide complete support for healthcare organizations and laboratories to achieve quality accreditation standards. We assist with documentation, SOP development, compliance implementation, audit preparation, application processes, and end-to-end guidance to ensure smooth accreditation and regulatory compliance.

4.CTRI Registration

CTRI Registration services provide complete assistance for clinical trial registration in the Clinical Trials Registry – India (CTRI). We support documentation, data entry, compliance review, application submission, and coordination throughout the registration process to ensure accurate and timely trial registration as per regulatory requirements.

5.QA/QC-Regulatory Intelligence & Monitoring

QA/QC – Regulatory Intelligence & Monitoring services ensure quality compliance and up-to-date regulatory oversight for clinical research and healthcare operations. We provide support in quality assurance, quality control, SOP review, audit readiness, regulatory updates, compliance monitoring, and risk management to maintain high operational and regulatory standards.

6.CRO Registration

CRO Registration services provide complete assistance in establishing and registering Contract Research Organizations (CROs) with proper regulatory compliance. We support documentation, SOP development, operational setup, regulatory coordination, and end-to-end guidance to ensure a smooth and compliant registration process.

7.Academic Trial Approvals

Academic Trial Approval services provide complete regulatory and ethical support for investigator-initiated and academic research studies. We assist with protocol documentation, Ethics Committee submissions, regulatory coordination, compliance review, and approval processes to ensure smooth and timely study initiation.

8.Sponsor Trial Approvals

Sponsor Trial Approval services provide end-to-end regulatory and ethical support for sponsor-initiated clinical trials. We assist with documentation, Ethics Committee and regulatory submissions, compliance management, coordination with stakeholders, and approval processes to ensure efficient and compliant trial initiation.

9.SAE Regulatory Reports

SAE Regulatory Reporting services provide comprehensive support for timely and compliant reporting of Serious Adverse Events (SAEs) in clinical trials. We assist with case documentation, causality assessment coordination, regulatory submissions, follow-up reporting, and compliance management as per applicable guidelines and timelines.

10.SOP Development & Review

SOP Development & Review services provide structured and compliant Standard Operating Procedures tailored for clinical research, healthcare, and regulatory operations. We assist in drafting, reviewing, updating, and standardizing SOPs to ensure operational efficiency, quality management, and regulatory compliance.

11.GCP Certification Course Training

GCP Certification Course Training provides comprehensive education on Good Clinical Practice guidelines, ethical research conduct, and regulatory compliance in clinical trials. Our training programs are designed for investigators, research professionals, Ethics Committee members, and healthcare teams to enhance knowledge, compliance, and research quality standards.

12.Medical Writing (Protocols, CSR, CRF design, Safety Narratives)

Medical Writing services provide professional support for the development of high-quality clinical and regulatory documents, including Protocols, Clinical Study Reports (CSR), Case Report Form (CRF) design, Safety Narratives, informed consent documents, and related study materials. We ensure scientific accuracy, regulatory compliance, and clear documentation to support efficient clinical research operations.