© 2019 by GBS

Integrated Services

“Our business model is primarily that of integrating our consulting services, asking the right questions, training and coaching so we can guide and support our clients with a customised plan, suited to their particular needs.”                                                                                                                 - GBS

Our customer-focused service modules are designed to help different types of clients get the services and expertise they need at the right level.  Whether you are just starting out and need basic training on GMPs, GDPs and GCPs, or you require ongoing support and oversight, or need to evaluate vendors to help you through the process, our service modules provide valuable combinations of assessment, training, staffing and ongoing review so you are supported for the long haul.

 

PACKAGES/MODULES – GBS offers service modules to guide our clients through the complexities of the clinical supply chain. Consisting of dedicated support, on-site project management, consulting and training, these programs pull together strategic services to give you the help you need to be successful and positively accelerate clinical and medical outcomes.

 

  • GMP Qualification (certification)

    • Flexible support for FDA systems approach audits and health authority audit preparedness.

    • Inspection-ready GMP documentation, processes, procedures and systems in compliance with CGMPs.

    • Maintenance program for 1 year-quarterly assessments; process mapping, SOPs and templates

  • GMP/GCP Company Start-up

    • Flexible support to put in place required GMP documentation and systems

    • Mandatory for GMP start-up

    • Quality Policy & Quality Manual

    • Company appropriate procedures and policies

    • GMP, GCP and SOP training

  • GMP Continuing Improvement

    • Gap analysis/risk assessment, process mapping

    • Quality oversight to determine more efficient processes and systems, best use and allocation of resources, incorporating lean principles

    • Annual GMP training

  • Clinical Supplies Management

    • On-site staff for project management support

    • Provide essential CS SOPs, flow diagrams

    • Instill lean principles

    • Training (GCP, Stakeholder support, customer support, communication & collaboration)

  • Supplier Qualification Program

    • Physical (in person) and desktop audits

    • Supplier questionnaire (evaluation) template

    • Supplier risk evaluation

  • ISO Certification Readiness

    • Readiness for ISO certification Identify gaps and areas for improvement

    • 9001:2015 - Plan for transition

    • 13485:2016

 

Training and Education

Building the right culture can be just as important as solving individual problems. We have an energizing and effective approach to training that engages audiences and builds enthusiasm for critical quality and regulatory processes...

         Compliance

We can help you build a culture of compliance.

Building the right culture can be just as important as solving individual problems. We can mentor and coach your c-suite and executives to help build a culture of support for supply chain...

Government

As a veteran owned business we support government agencies and institutions to assist them with consulting and training in many different areas of R&D. We have done work with the NIH and...