Aggregate Safety Reporting
We compile and deliver safety reports, including IND Annual Reports, Clinical Study Reports, DSURs, ASRs, PSURs, PBRERs, PADERs, NDA, ANDA. Our services involve utilizing the PSO/ACO methodology for classification and rule discovery in postmarketing surveillance or pharmacovigilance.
This service meets the needs and obligations of the MAH surveillance team to comply with current legislation.
Don’t hesitate to contact us for more information.
Why is it important?
Vigilance is a key responsibility of the MAH and therefore our dedication is addressed to ensure the safety and efficacy of human health products, especially pharmaceuticals, throughout the product life cycle, from development to post-marketing”.
The safety problems of pharmaceutical products are the most feared, along with those of manufacturing quality. They can lead to the withdrawal of a drug, the recall of a batch or even the recall of a producto.
Why QbD Group?
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
