Regulatory consulting for medical device and IVD companies
Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Regulatory Consulting by Region
Pepgra has done plethora of work in the area of clinical trial audits and monitoring for top pharmaceutical companies. Our CRAs will ensure a thorough review of data, frequent the sites, and perform interim analysis. All tasks in compliance to ethics committee and regulatory standards such as Schedule Y, study protocol, ICH GCP and the other regulations.
We deliver study designs balanced to meet your business needs and expectations with the current scientific understanding and all regulatory requirements considered.
Allow us to help propel your product forward.
Pepgra CRAs did a fabulous job of frequenting the clinical trial sites at different times during the course of study. Apart from their technical know-how, they also had a great affinity with our site team members and finally documented pivotal research findings in the monitoring report which was an eye-opener for us. I would strongly recommend Pepgra as the CRO of choice.
— Barry Stein, VP of a leading medical device manufacturer.
up as your needs grow.
No compromising on integrity and quality. Our processes are well defined and flexible to ramp up as per your requirements.
you till the project end.
We come with you all the way. From design to market support
Pepgra CRO Offerings
"Changing global regulatory system, globalization of clinical trials, increased consumer expectations, infrastructural and culture issues, and various diagnostic requirements should never hamper your research and development programs. With our support..."
Download brochure on our CRO offerings (PDF).