Consulting company in the field of GMP inspections
We support pharmaceutical companies, contract manufacturing organizations, and manufacturers of medicinal and veterinary products and dietary supplements at all stages of the GMP inspection process.
We work with inspections in format: on-site and remotely, ensuring clear communication with regulators and transparency at every stage.
Create a clear, effective, and transparent path for interaction between the customer and the Health Authorities, providing high-quality services related to supporting GMP inspections in accordance with EAEU regulations
Our Value
Competence and transparency
We do not promise the impossible, but make realistic forecasts based on facts and regulatory practices.
Responsibility to clients and regulators
We act ethically and professionally.
Flexibility and adaptability
We work in various formats: remotely, on-site, in Russian and English languages.
Confidentiality
All projects are protected by non-disclosure agreements (NDAs) and internal information security procedures.
Who are we
GMP Solutions is a consulting company specializing in supporting GMP inspections for the pharmaceutical, veterinary, and dietary supplement inductries. We help Russian and foreign manufacturing plants pass inspections and obtain GMP certificates that meet the requirements of the Russian Federation and the Eurasian Economic Union (EAEU).
Our company has professionals with experience in participating in GMP inspections conducted by regulators from the Russian Federation and the Eurasian Economic Union, as well as experience working in international pharmaceutical companies (RA, QA, Production field etc.).
Where we operate
We understand the local realities and regulatory requirements in each of these regions. We adapt the format of interaction to the specific country and client.
We work with applications in Russia according to EAEU regulations. Our team also supports GMP inspections when submitting applications in the following countries:
Russia
Belarus
Kazakhstan
Armenia
Our Clients
Manufacturers of prescription and over-the-counter products (Rx or OTC)
Manufacturers of dietary supplements and nutraceuticals
Manufacturers of veterinary products
Contract manufacturing organizations (CMOs)
Representatives of foreign companies/Distributors entering the Russian and EAEU markets