The Risk of Imprecise
Communication in a GMP Audit

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In a high-stakes inspection, such as one from the EAEU, the precision of communication is not a detail — it is a critical success factor. A generalist interpreter, without experience in the pharmaceutical sector, can introduce significant risks:

It can lead to misunderstandings of technical terminology

related to processes, equipment, and regulations.

It compromises the ability to convey the context

and scientific justification for the manufacturer’s procedures.

It creates an impression of a lack of control

or preparation before the inspectors.

It increases the probability of receiving observations

due to poor communication.

A Linguistic Service Designed
for the Pharmaceutical Industry

Our service is exclusively focused on supporting pharmaceutical, biotechnology, and medical device companies. We provide precision and fluency in the following types of inspections and audits:

GMP inspections for human medicinal products.

GMP inspections for veterinary medicines.

Inspections of medical device manufacturers.

Pharmacovigilance inspections.

Audits of third parties (suppliers and CMOs).

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Our teams provide interpreting services in Russian, Spanish, English, Korean, Polish, Greek, French, and German.
Contact us

Specialization That Reduces Inspection Risks

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Specialization is the foundation of quality. These are the pillars of our service:

Proven Experience:

Since 2014, we have participated in over 600 inspections and audits. We understand the dynamics of the process thoroughly.

Exclusive Specialization:

We are not a generalist translation agency. We work solely within the pharmaceutical sector, primarily covering inspections and audits from the Eurasian Economic Union (EAEU) and South Korea.

Spain-Based Company:

We offer the security and simplicity of a European contract, with the agility and reach of a global partner.

Global Coverage with Local Teams:

We have our own interpreting teams in Spain, Poland, Italy, Greece, the United Kingdom, Ireland, Belgium, France, and South Korea, ready to travel to manufacturing sites.

Regulatory Knowledge:

We possess a deep understanding of the requirements and expectations of inspectors from the EAEU countries and South Korea.

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OUR WORK PROCESS

To ensure success,
we follow a structured and proactive process:

1

Initial Consultation

We analyze the manufacturer's specific needs, the product characteristics, and the inspection agenda.
2

Team Assignment

We select the most suitable interpreters for the manufacturing technology and product type to be inspected.
3

Technical Preparation

We study key documentation (specifications, flowcharts, SOPs) to prepare a contextual glossary and familiarize ourselves with the production and control processes before the inspection begins.
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Other GMP Support Services

In addition to linguistic support, RuGMP assists manufacturers in other areas. Our services also include:

Consulting and Mock Inspections:

Pre-audits conducted by expert auditors and former inspectors to assess the degree of compliance with EAEU and EU GMP regulations.

Training Programs:

Practical, case-based training to prepare the team for inspections and align their work with inspectors’ expectations.

Prepare for Your Next Inspection

Precise communication is the key to a successful audit. Having a team of specialists who understand the pharmaceutical sector is the foundation for a smooth process.

Complete the form to request more information and discuss your project needs.

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