In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).
An effective quality system is critical to compliant research and thus regulatory approvals.
Whether you're looking to resource a single audit, develop or manage an entire audit program, or bring in an interim quality assurance manager to support your team, Halloran provides experienced, cost-competitive, and responsive quality and compliance services for Good Clincal Practice (GCP) and Good Laboratory Practice (GLP).
At INC Research/inVentiv Health the Quality Assurance (QA) team interacts directly with clients to understand the specific requirements for their product development project.
Ropack Pharma Solutions offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages into blisters, bottles, flip-top vials, stick-packs and sachets.
Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.
One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.
As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.
One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.
All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders.
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