Regulatory Affairs & Compliance Solutions
The Situation Today
The pharmaceutical industry is going through a challenging time in terms of ensuring compliance with the regulatory requirements while utilizing the latest technologies. Though these technologies have helped in improving the processes, ensuring regulatory compliance has been more difficult.
How HCL Can Help
HCL’s Life Sciences Quality Management System (LSQMS) is integral to every engagement in the pharmaceutical domain. LSQMS complies with FDA regulations affecting IT development and supports all the applications in this space. HCL’s regulatory and compliance team acts as an internal checkpoint and ensures that all the applications are compliant before they are deployed at the clients’ location. In addition, the team trains internal QMS auditors and the technical team on how to document the development process and ensure that it complies with the FDA norms.
HCL has established a Regulatory Affairs and Compliance Centre of Excellence (CoE) together with industry leaders who have an excellent understanding of GxP requirements for the entire pharmaceutical product lifecycle. Experts with hands-on experience in validating computer systems according to FDA norms and those of other international regulatory bodies are a part of the CoE.
HCL’s regulatory affairs and compliance capabilities include:
- Risk-based computer system validation in alignment with GAMP 5
- GxP documentation and Internal audits
- Regulatory dossier submissions for drugs, devices and medical devices for multiple geographies
What You Can Expect
End-to-end solutions in
- Validation and regulatory compliance
- Regulatory submission of drugs , devices and biologics (for life science companies)
For more information, write to us at: email@example.com