vi-pharma-headerv1-smThe 8th Annual Pharmacovigilance Conference will be held at the Marriott Marble Arch Hotel, London on the 24 – 25 February 2015. This conference represents an important opportunity for Pharmacovigilance stakeholders to discuss and share the current best practices for expediting Pharmacovigilance development in their organisations.
The conference will bring together leading pharmaceutical, biotechnology and regulatory representatives under one roof to address the key Pharmacovigilance issues in industry today, including how to avoid common deficiencies in Pharmacovigilance compliance activities by offering an opportunity to learn from the experiences of others via case studies and first-hand industry experiences.
Do you require assistance with your GVP auditing requirements?

Have you had a recent audit or inspection finding against a particular GVP process?
At ADAMAS, we place significant emphasis on adding value to the GVP service we provide to our clients. In response to industry trends and our client needs, we are continuously developing our service offerings to ensure we remain at the leading edge of GVP consultancy services worldwide. We believe that from concept to delivery, ADAMAS is uniquely placed to ensure our clients GVP compliance activities are at the forefront of industry best practice.
In 2013/2014 alone, ADAMAS conducted GVP audits in over forty countries, successfully managing global affiliate, business partner and service provider audit programmes for several pharmaceutical organisations. Our in-house GVP consultancy team has been carefully developed, based on the principle of genuine Pharmacovigilance experience, and includes former Industry and Competent Authority professionals. This level of experience ensures that we not only possess a deep understanding of the applicable regulatory requirements, but we can also deliver first-hand experience on how these requirements are applied pragmatically in industry today.
In addition to our GVP systems audit service, we also offer a unique tailored GVP process audit service, representing an opportunity for our clients to focus their compliance activities on the systems and processes where they are most needed.
At ADAMAS, we have successfully assisted organisations in preparing for their Regulatory Authority inspections. Our GVP team possesses the necessary skills and experience to guide and advise organisations through the inspection preparation, conduct and follow-up stages according to their needs.
ADAMAS Consulting will be exhibiting at the 8th Annual Pharmacovigilance Conference from 24 – 25 February 2015.
Come and meet ADAMAS team at stand #1 for further information on any of the above services, or to discuss any other aspect of your Pharmacovigilance compliance requirements.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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