Auditing of client's facilities and operations forms a major part of our activities.

We all have decades of experience of auditing and we have the expertise to be able to audit any type of activity - from Research and Development through to distribution activities, from active pharmaceutical ingredients to all types of dosage form manufacture - against all the major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and numerous others.

Several of our staff are former UK regulatory inspectors, whilst others have held senior corporate compliance auditing positions with major multinational pharmaceutical companies.

Because of our experience we are able to provide simple and pragmatic advice that will benefit you, your patients and your business.

The types of audit we regularly perform include .

Third Party Audits

We can assist you in your search for the ideal contractor by performing audits on your behalf to any GMP standard you wish.

We can assess potential contract services for .

and a range of other vendor and supplier services.

We will provide you with a detailed but balanced report, highlighting .

There are numerous advantages to using an independent organisation such as ourselves for this work.

"Benchmarking" Audits: Lets us help you improve your overall efficiency.

Sometimes it can feel very lonely in the pharmaceutical industry.

You work hard to implement technology and systems to provide what you consider to be an acceptable level of quality assurance and GMP compliance in your company, but it is often very difficult to know whether what you are doing is in line with current industry "best practice" and how you compare with your major competitors.

This is where we can help.

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 to provide you with that key information . "Are we well up with current industry standards? Have we gone over the top? Where do we stand?"

We can help you to assess your position in the marketplace and can provide sound, commonsense advice on how to move forward.

Mock Regulatory Audits

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.

Consultants from David Begg Associates will visit the client's facility and play the role of regulatory inspectors to carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMEA etc.).

Such an audit has several advantages for the client .

They receive an in-depth, impartial and professional assessment of their current state of compliance with the regulatory expectations of the relevant authority.
They receive a detailed, prioritised action plan for the rectification of areas of non-compliance and vulnerability so that improvements can be made or position statements prepared before the actual inspection.
Their staff receive vital "training" in the sorts of questions which are likely to be asked during the inspection and how best to answer these questions, so increasing the confidence level within the company.
They receive sound, practical support and advice in the run-up to the inspection itself.

EU and FDA Inspection Readiness:

We have extensive experience of preparing companies throughout the world to MHRA or other EU regulatory inspections and our "success rate" is enviable.

Perhaps more surprising is our excellent record of preparing European clients for FDA inspections. We offer many advantages over US based consultancies in this respect .

We are totally familiar with FDA regulations and expectations during inspections, resulting from our work with US based clients.
We have practical experience of how FDA carry out overseas inspections, whereas many US consultancies have experience only of domestic investigations, which are very different both in duration and focus.
We are Europeans with strong cultural links to Europe but we also share a common language with the USA and we understand the US mentality. This allows us to "bridge the gap" between European and US philosophies.
We are based in Europe, so the cost of using our services is lower than using US based consultancies, and we are more accessible for support in the final preparation phases.

Troubleshooting and Problem Solving

When you are very close to a problem it can become difficult to solve. A 'fresh pair of eyes' can often help you solve problems - quickly. Our team have considerable expertise with helping companies to systematically resolve problems associated with their products, processes, equipment and systems.

Due Diligence Audits

We regularly assist pharmaceutical companies, investment banks etc. in the process of due diligence for potential acquisitions, buy-ins, joint ventures and other investment projects.

Whilst others assess the financial health of companies, we can perform an in-depth assessment of the regulatory compliance status of companies and/or projects by reviewing .

Status of marketing approvals, applications etc.
Current complaints, adverse reactions etc in order to assess vulnerability
Current relationships with the major regulatory authorities
The quality of staff in key technical positions
The general levels of GMP compliance and investment needed to maintain GMP compliance in the short, medium and long term

The frequency of enquiries from European investment banks and venture capital organisations attests to the quality of our work in this area.

Please feel free to e-mail us with your specific problem. We will do our best to assist.

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