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Offer

Learn about the full scope of support we can provide when we work together

Audits
GMP audits
ISO standards audits
GDP audits
Internal audits
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Consulting
Preparation and support: inspection, certification and audit
Optimization of production processes
Personnel trainings
Consulting and support during QMS implementation and life cycle
Temperature mapping
Book a meeting
Analysis
Risk analysis in accordance with ICH Q3D guidelines
Cross-contamination risk analysis
Risk analyses related to nitrosamine contamination
New Psychoactive Substances qualification
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Support at all stages
Don't see a solution for you in our standard offer? No problem! Explain your needs, requirement and tell us more about your business environment and we will find the best way for you.
Book a meeting

Take a look at our full range of services

Audits of medicinal product manufacturers (GMP part I, 21 CFR Part 211)
Audits of API suppliers (GMP part II, ICH Q7, 21 CFR Part 210)
Audits of excipients suppliers (IPEC, EXCiPACT, ISO 9001, ISO 22000)
Audits of primary packaging materials (ISO 9001, ISO 15378, PS 9000)
Audits of transportation companies (GDP, GMP, ISO 9001, ISO 22000)
Audits of distributors (GDP, GMP, ISO 9001, ISO 22000)
Internal audits
Preparation for inspection and certification
Support in post-inspection and post-audit activities
Risk analysis according to ICH Q3D guidelines
Cross-contamination risk analysis
Risk analyses related to nitrosamine contamination
Classification of new psychoactive substances (Attachment to the Regulation of the Minister of Health of August 21, 2019. (Item 1745)).
Consulting and support during QMS implementation and life cycle
Creating procedures and working instructions
Consultation on optimization of production processes
Personnel trainings
Temperature mapping
Have questions? Write to us

Frequently asked questions

How long it takes to conduct an audit

The duration of the audit depends on its scope and complexity.
Most often, the audit is conducted in one business day. The first version of the report is delivered within 7 business days.
Do you offer personnel trainings?

Yes. Our offer includes training in:
- GMP
- GDP
- ISO 9001
- ISO 15378
- ISO 22000
- IPEC and EXCiPACT
- ISO 19001
After contacting us, we are able to adjust the schedule to meet your needs.
What are the costs of your services?

We determine the cost of our services based on the scope of work.
We present the offer individually. Each element of our work is described in detail.
Usually, the offer is preceded by a free meeting (including online), during which we determine the scope of work and collect and provide the necessary information. The quote is free.
For more information, please contact us.
Who can use your services?

In fact, any company, organization or public entity that wants to optimize its processes and services. Implementing the rules that are required by regulatory or certification bodies, as well as by your customers, allows for effective control over the product manufacturing process, thus avoiding many unpleasant events, such as: loss of certificate, non-compliance of products with registration documentation, loss of customers. Moreover, in accordance with regulatory provisions, handling medicinal products allows us to avoid administrative penalties on the one hand and loss of the company's image on the other.