We have decades of experience of auditing and we have the expertise to be able to audit any type of activity, from R&D through to distribution activities, from active ingredient to all types of pharmaceutical dosage forms.
Several of our staff are former regulatory inspectors, while others have held senior corporate compliance auditing roles with major pharmaceutical companies.
The types of audit we regularly perform include:
We can assist you in your search for the ideal contractor by performing audits on your behalf to any GMP standard you wish.
We will provide you with a detailed but balanced report, highlighting:
Our constant exposure to pharmaceutical companies, large and small, on a worldwide basis allows us to be able to assess your facilities, procedures, and practices against current industry norms and best practices. We can help you to assess your position in the marketplace and provide sound advice on how to move forward.
We regularly assist clients to prepare for an imminent regulatory inspection by carrying out one or more "mock" regulatory audits in advance of the real thing.
We will play the role of the regulatory inspectors to carry out an inspection in the style of the relevant regulatory agency.
Following the audit, you will receive:
We regularly assist pharmaceutical companies and investment banks in the process of due diligence for potential acquisitions, joint ventures, and other investment projects.
While others assess the financial health of the business, we can perform an assessment of regulatory compliance, etc.
The frequency of enquiries from investment banks and venture capital organisations attests to the quality of our work in this area.
If you would like to discuss how David Begg Associates can assist you, please call 617.342.3625 or email us at USinfo@DBA-global.com.