Industry - Current Focus
In recent years, healthcare and pharmaceutical industry has experienced a dramatic rise in the number of investigations, audits and remediation enforcement actions from the governing regulatory bodies.

Failing to comply with the stipulated regulations have resulted in situations such as loss of manufacturing license leading to temporary closure of units, impact on product sales with financial loss, accidental and intentional loss of valuable data and negative impact on brand image.

This has forced the industry players to focus on complying with the various laws (local, national and international) to ensure they do not lag behind in the fierce competition to succeed.

Necessity of Compliance
Today’s global nature of business entails interaction with regulatory bodies across the world like US FDA, EMEA, MHRA, DCGI, TGA, and Japan MHLW. The diverse and complex nature of regulations to be followed at various parts of the world is a compelling reason for pharmaceutical companies and healthcare providers to be well equipped with compliance needs in advance.

Wipro HLS Regulatory Services

Who We Are
Wipro Regulatory Services practice consists of highly qualified group of consultants with extensive regulatory experience in the areas of pharmaceutical, biotech, medical devices, payer and provider industry.

We have rich experience that is combined with the knowledge of FDA, EU and country specific regulations such as

• 21 CFR Part 11
• Computer System Validation (CSV)
• 45 CFR 46, 21 CFR 50, 21 CFR 56 (federal regulations for the field of human subject research)
• HIPAA
• EMEA regulations
• Standards such as HL7, CDISC, NCICB UI Standards with Section 508 compliance and caDSR
• Guidelines such as ICH-GCP, GMP and GLP

What We Do
The growing trend of increasing productivity using information technology and process automation has created new breed of regulatory concerns. Inadvertent disclosure of patient information, probable leakage of R&D data, unauthorized access to confidential information and inability to interact between multiple systems within the same organization are few major issues that organizations face today.

The extensive knowledge base in our regulatory consulting practice is uniquely positioned to address these concerns. Our service offerings ensure that the client assess the regulatory risks and remediate in time that makes them the front runners.

Service Offerings
Broadly, our service offerings can be grouped under three categories:

• Consulting
  • Computer System Validation (CSV)
  • 21 CFR Part 11 compliance
  • Regulatory Best Practices Consulting (GxP)
  • Medical devices validation services
• Solutions
  • Electronic Research Information and Compliance (eRIC)
  • Regulated Document Management Solution (RDMS)
  • Regulatory eCTD submission
• Managed regulatory compliance services

Please click on the links above to see our offerings in each of these areas.

For additional information regarding our regulatory services Please write to Jeyseelan Manager of regulatory practice at jeyaseelan.jayaraj@wipro.com