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Pharmaceuticals 

At Reglysis, our Pharmacovigilance Solutions are meticulously designed to ensure drug safety and maintain regulatory compliance throughout every stage of product development and post-marketing. From initiation to completion, we offer a full spectrum of services, including adverse event reporting, signal detection, risk management, and regulatory submissions. Leveraging our team's extensive expertise and cutting-edge technology, we provide streamlined and compliant processes that enhance operational efficiency. Our mission is to assist pharmaceutical companies in meeting evolving global safety standards while prioritizing patient health.

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Medical Devices

Reglysis delivers consulting services across industries, tailored to the evolving operational and strategic requirements of organizations in areas such as data management, documentation, and compliance support. Our comprehensive services enable you to concentrate on core objectives while we seamlessly integrate as an extension of your team, ensuring compliance and operational efficiency.

Clinical Evaluation Reports

Reglysis prepares Global Clinical Evaluation Reports (CER) to ensure medical device safety, performance, and compliance with international regulatory standards.

European Union (EU) Authorized Representative Services

Reglysis provides EU Authorized Representative services, ensuring non-EU manufacturers comply with MDR/IVDR, meet safety standards, and maintain seamless market access

Medical Device Global Consulting

​Reglysis offers expert consulting to navigate global medical device regulations, supporting manufacturers from development to market approval and compliance.

Post-Market Surveillance 

Reglysis delivers Post-Market Surveillance services to ensure medical device safety, performance, and regulatory compliance, helping manufacturers mitigate risks and protect patient health.

Cross- Industry

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Reglysis provides cross-industry consulting services tailored to the dynamic operational and strategic needs of organizations, specializing in areas such as data management, documentation, and compliance support.
Our comprehensive suite of services enables you to focus on core operations while we act as an extension of your team, ensuring efficiency and regulatory compliance across industries.

Quality Management

Reglysis provides Quality Management services to ensure medical devices meet safety, efficacy, and regulatory standards like ISO 13485 and GMP, supporting manufacturers in delivering high-quality products.

Project Management  Services

Reglysis ensures timely, compliant, and quality-driven delivery of medical device projects through expert project management.

Risk Management Services

Reglysis offers Risk Management Services to ensure medical devices meet safety and regulatory standards, focusing on risk identification, mitigation, and compliance with ISO 14971.

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Contact Us

Address

C6, Sainikpuri. \Hyderabad, TG, 500011 India

​

1302 E Collins Blvd, Richardson, Texas, 75081 US

Contact

+1-574-398-2485

+91-9676769534

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Opening Hours

Mon - Fri

8:00 am – 6:00 pm

Saturday

Closed

​Sunday

Closed

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