What We Do

This A GMP audit is a source of stress for any manufacturing facility, even more so when there is a language barrier between you and the inspectors.
It does not have to be this way. We know how to remove this unnecessary stress. We’ll make sure you are not constantly wondering what exactly the auditors want from you. Nor will you have to worry about whether your explanations have been correctly understood. All questions will be accurately translated into your preferred language, and your answers will be transmitted to the foreign inspectors in full, without any omissions or additions.

Clear language, unambiguous technical vocabulary, instant reaction, no unwanted pauses – it’s all part of a fluid flow of communication. You and the inspectors won’t have to strain your brain to understand each other, so you can concentrate on what really matters, i.e. your inspection plan. As a result, the audit will go more smoothly in a friendly and comfortable atmosphere.

GMP audits cannot be improvised. We are professionals, with dozens of similar missions under our belt, and we are confident: there will be no surprises.

Who We Are

A Team of language professionals (working for the World Health Organization and other UN bodies, European Institutions  and the Council of Europe)

We specialize in translation for the medical and pharmaceutical industries.

50+ successfully completed audits worldwide

Advanced training in Good Manufacturing Practices

Our own translation equipment

While our main focus is on companies where English, French  and Dutch are spoken, we have built up an extensive network  of professional contacts over the years. This allows us to provide support in other languages such as German, Italian, Spanish,
etc. if required.

Anton Klevansky

15+ years of top-level experience
1500+ completed translation projects
Certificate of advanced training in GMP from the First Moscow Medical University

More about Anton

David Babaev

Professional interpreter and simultaneous
interpretation teacher
2000+ completed translation projects
Continuous professional development in the field of pharmacology and GMP

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David Babaev

Professional interpreter and simultaneous
interpretation teacher
Continuous professional development in the field of pharmacology and GMP

More about David

Our Services

We assist you throughout the duration of the audit by providing you with:

Consecutive interpretation

We translate the inspector’s question, listen to your answer, and then accurately translate it back to the inspector. This is how most audits are conducted.

Simultaneous interpretation

In certain contexts, simultaneous interpreting can present some advantages, especially during site visits or general meetings. We translate in real time without interruptions, allowing for a smooth flow of communication. Participants can hear our voices through special equipment. While organizing simultaneous interpretation may not always be possible, sometimes it can save a considerable amount of time and bring dynamics to dialogue.

Translation

We are ready to translate any documents before, during and after the inspection.

How we work

Audits usually take one of the two forms:

On-site audits

Where the inspectors come to the production site in person

Remote audits

Where a conference call is organized with the inspectors. If you are preparing for a remote audit – we can advise you in detail on the platforms and equipment that will allow everyone to hear better and fully benefit from translation. Also, after considering the pros and cons of your particular situation, we will decide whether the interpreters should be physically present on the site, or whether it would be acceptable for them to join the meeting remotely as well.

At the outset, we discuss the format of our cooperation in detail with key audit participants by email or via a video call

We sign a non-disclosure agreement – we guarantee that no document shared with us will be leaked into the public domain.

We start preparing ourselves for the inspection. For the whole duration of the inspection, we become the face of your company, which means we need to understand and internalize its mission and values.
We study all publicly available information. We will also ask you to send us additional material whenever possible.
Sometimes, if the processes are really complex or unusual, we visit the production in advance at the invitation of the organizers.

On the day of the audit, we will arrive at the production site on time, at least half an hour before the inspectors (or, if the audit is remote, we will connect ourselves in advance). We’re never late. After a few hours you will stop noticing us – you will feel you are speaking the same language as the inspectors.

After the audit, we are happy to attend the final debriefing, listen to recommendations and any criticisms so that we can deliver a higher quality service next time.

You will enjoy working with us

Competence

We understand and we know what’s going to happen. Not only we’ve honed our translation skills, but we’ve also got a really good grasp of the GMP-related issues. We specifically studied GMP and audit organization at the Moscow Medical University.

Reputation

We are well known in many big pharma companies. Outside the pharmaceutical industry, we have a wealth of experience working at the highest levels for major international organizations, governments, kings and presidents. We are respected and recommended by many of our peers.

Confidentiality

We adhere strictly to professional ethical standards and ensure that no information obtained during the audit is disclosed to third parties. All documents received in preparation for the audit will be destroyed without possibility of recovery. We are willing to sign the strictest confidentiality agreements.

Flexibility

Every production site is unique. We will listen to what you need and try to come up with the best solution.

Customers
about our work

Marc Helouin

Quality & Regulatory | Biotechnology & PharmaceuticalsTransformational Business Leader | Quality & Regulatory | Biotechnology & Pharmaceuticals

Our site in France was very fortunate to secure Anton's services in the support of multiple health authority inspections by Russian and Kazakh authorities over the last few years. Anton's ability to manage complex and precise translations in English, French and Russian (in real time) was critical to the positive outcome of all inspections for which he has acted as translator. Anton is our "go to" translator for mission critical translation support when dealing with Russian speaking authorities. I recommend Anton with enthusiasm and without hesitation.

Cédric Allenou

Co-fondateur d'Officine et stratégie et pharmacien d'officine

Après avoir travaillé à plusieurs reprise avec Anton je le recommande plus que vivement dans le domaine que j exerce à savoir de le domaine médical et pharmaceutique.Il maîtrise parfaitement l anglais et le francais appliqué à l’industrie pharmaceutique, il en connaît les codes , les acronymes, les expressions dédiés.C’est un réel plaisir et confort de travailler avec lui. Il apporte dans chacune des traductions une forte plus value et sécurité. Merci a Anton pour son travail et son aide et à bientôt pour de nouvelles traductions

Contact

Messenger

Anton Klevansky

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Language Consulting
for GMP audits

Ensuring Efficient Communication with Russian-Speaking Inspectors

For a few days of the audit, we will act as the face of your company, helping you present it in the best possible light to the inspectors

What We Do

Who We Are

While our main focus is on companies where English, French  and Dutch are spoken, we have built up an extensive network  of professional contacts over the years. This allows us to provide support in other languages such as German, Italian, Spanish,
etc. if required.

Anton Klevansky

David Babaev

David Babaev

Our Services

We assist you throughout the duration of the audit by providing you with:

How we work

Audits usually take one of the two forms: