
The critical role of REMS measures in ensuring patient safety
Managing the safety profile of pharmaceuticals and medical devices is crucial; comprehensive REMS measures ensure regulatory compliance, mitigate risks and transform patient safety outcomes.

Embracing the assurance-centric approach
In Sep 2022, the FDA introduced CSA guidelines to streamline tech adoption in pharma and biotech, enhancing efficiency and patient care.

HCLTech Regulatory Intelligence
Unlock the future of compliance with GenAI-powered Regulatory Intelligence, which automates data collection, summarization and reporting to stay ahead of the dynamic regulatory environment.

Obsolescence Engineering Services for the semiconductor ecosystem
Learn more about how HCLTech can help you transform the semiconductor ecosystem with our Obsolescence engineering services.

AlertAE: Next-gen pharmacovigilance solution
Intelligent identification and classification of adverse events, product quality complaints and clinical queries

HCLTech positioned as a Leader in Everest Group’s Connected Medical Device Services PEAK Matrix® Assessment 2022
Everest Group recently released its report titled " Connected Medical Device Services PEAK Matrix® Assessment 2022" where they analyze the changing dynamics of the Medical device services landscape.

MedTech industry adjusting to impact of EU-MDR regulations
The implementation of regulations on medical devices in the EU has MedTech companies making moves to update regulatory documents

Ensuring safety and innovation while integrating AI into medical devices
As the healthcare industry increasingly embraces AI, organizations need to be prepared to address the emerging regulatory challenges

Enhancing herbal, supplemental and OTC product regulatory compliance
Rising demand for natural and alternative health products spurs market growth and calls for strict regulatory oversight to ensure safety and compliance


GenAI and its potential for medical device post-market surveillance
Learn how GenAI can transform medical device post-market surveillance by automating data retrieval and analysis, enabling stakeholders to make swift, informed decisions.

Compliance
Key Compliances for Designated Persons under the Insider Trading Code and Fair Disclosure Code