About Us

Company Overview

Scitus pharma Services Private Limited is one of the leading contract research organizations located in Chennai in the southern part of India. We deliver our services with Quality, Ethics, and Compliance to the standards set by the major regulatory agencies around the world.

Our systems and processes are designed to meet the regulatory-specific requirements during our research conduct. Scitus Pharma Service is committed to offer competitive clinical trial services to domestic and international pharmaceutical and bio-pharmaceutical companies.

Scitus Pharma has the expertise to conduct clinical trials in various therapeutic areas such as Oncology, Psychiatry, Gynaecology, Pain management, Dermatology, etc., for submission to regulatory agencies across the globe.

Established in September 2017, our primary focus is to support pharmaceutical and biopharmaceutical industries in their quest for developing NCEs and generic drug products by conducting bioavailability and bioequivalence studies on healthy volunteers and patients and Phase II to Phase IV clinical trials. Our high level of technical competence and customer focus will ensure that our customers are assured of high quality deliverables while we maintain highest standards of quality, ethics and compliance.

In addition, with the support of our partner organizations, Scitus encompasses a diverse portfolio of capabilities to assist the pharmaceutical companies intending to develop generic drug products from Active Pharmaceutical Ingredients to formulation development of conventional and novel drug delivery products, analytical development, stability, clinical development and regulatory support for ANDA submission.

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Why Choose Us

  • A well experienced team of scientists who have long years of experience in bioanalytical processes, capable of handling complex molecules and endogenous molecules
  • Compliance with regulatory guidelines, and maintaining standards of excellence, efficiency & speed to meet timelines
  • Vast experience and in-depth understanding of the stringent regulatory demands to ensure that each project is accomplished with rapid turn-around timelines
  • A rich past experience with regulatory inspections including US FDA, WHO, EMA, ANVISA, TGA, Health Canada, GCC and NPCB
  • Efficient project management to ensure that projects are completed in the shortest time possible
  • An independent and experienced Quality Assurance unit to ensure compliance of the generated data as per the regulatory guidelines and SOPs

Our Mission & Vision

Our Vision

To be known globally as a reputed CRO offering services for the entire spectrum of drug development in support of regulatory submissions.

Our Mission

To achieve and maintain highest standards of quality and compliance in all our deliverables, to ensure faster turnaround time in project deliveries, and to pursue excellence through science and technology.

Our Values that Shape Us

At Scitus, we are committed to delivering the service with Quality, Ethics, and Scientific research organization and are designed to meet the regulatory-specific requirements during our research conduct.

Quality

Ethics

Compliance

Strength

The Quality Assurance from Scitus

Our quality assurance team meticulously focuses on quality at various stages of study conduct/deliverable and implementation of various procedures/controls, ensuring process uniformity, consistency, and standardization across the organizations.

The team conducts system audits for all areas in order to verify/ensure compliance with the Standard Operating Procedure and current Regulatory requirements of major regulatory agencies, and vendor audits as per our in-house procedures.

Our Business Ethics

  • We consistently meet our customer’s expectation of quality & project delivery
  • We meet ethical standards in clinical practices and use validated methodology in analysis
  • We meet timelines for reports and regulatory submissions
  • We seek continuous improvement of our systems and practices
  • We employ highly trained and experienced personnel
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Years of experience under a strong leadership team
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CFR Compliant Systems for documentation security

GCP

GCP compliant processes and practices

Our Exceptional Operational Strength

  • Strong Leadership with >15 years of experience
  • 21 CFR Compliant systems
  • GCP compliant processes and practices
  • 170+ highly skilled & experienced scientists
  • 5 Years of Excellence in Clinical Research
  • Maintaining Integrity during delivery
  • Faster project turnaround times