Regulatory Solutions

  1. GCP & GLP Audit Services
    8/19/2014

    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). 

  2. Quality Assurance: Clinical and Bioanalytical
    5/29/2013

    At INC Research/inVentiv Health the Quality Assurance (QA) team interacts directly with clients to understand the specific requirements for their product development project.

  3. Contract Packaging Services For Clinical Trials
    5/2/2013

    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.

  4. Central Laboratory Solutions
    4/23/2013

    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.

  5. Study Start Up
    4/23/2013

    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.

  6. Global Pharmacovigilance And Safety Solutions
    4/23/2013

    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.

  7. Pharmacovigilance System Master File
    4/23/2013

    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.

  8. Electronic Regulatory & Study Binders
    4/23/2013

    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.

  9. Global Multilingual Call Center
    4/23/2013

    TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).

  10. Electronic Trial Master Files
    4/23/2013

    As life sciences companies move to semi-virtual environments keeping only the most vital functions in house, more and more Trial Master Files are being converted to an eTMF format.