Parexel International India Safety Services

Parexel International India Safety Services is a service provider. It is neither a factory (manufacturer of goods) nor a trading company (buyer and seller of goods). It offers professional services in the life sciences sector.

Here is the company profile:

Company Overview:

This entity is a key part of Parexel International, a leading global Contract Research Organization (CRO). CROs provide a comprehensive range of professional services to the pharmaceutical, biotechnology, and medical device industries.

The "Safety Services" division, primarily based in India, specializes in Pharmacovigilance (PV). Pharmacovigilance involves the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products. Their services include, but are not limited to:

Adverse event processing and case management

Aggregate safety reporting (e.g., PSURs, DSURs)

Safety signal detection and evaluation

Risk management plan development and implementation

Literature surveillance

Regulatory intelligence and compliance support

Parexel International India Safety Services plays a crucial role in ensuring drug safety throughout the product lifecycle and helps its clients meet stringent global regulatory requirements. Their clients are typically pharmaceutical, biotechnology, and medical device companies worldwide who outsource their drug safety and pharmacovigilance operations to Parexel. In essence, they contribute significantly to the safe and effective development and post-market surveillance of new therapies.

Parexel International India Safety Services primarily provides specialized services to the pharmaceutical, biotechnology, and medical device industries. They do not manufacture or sell physical products. Their offerings are in the domain of drug safety and pharmacovigilance.

The services they produce or sell include:

Pharmacovigilance Consulting

Individual Case Safety Report (ICSR) Processing

Aggregate Report Writing (e.g., PSURs, DSURs, PBRERs)

Risk Management Plan (RMP) Development and Implementation

Signal Detection and Management

Medical Literature Surveillance

Safety Database Management and Maintenance

Medical Monitoring

Post-Marketing Surveillance

Safety Audits and Inspection Readiness

Pharmacovigilance System Management