Main / Other services / Obtaining a certificate / conclusion on GMP confirmation

Do you want to get a GMP certificate or confirm it in Ukraine?

We have been doing this for over 15 years! Here you will receive a range of services for organising the obtainment of a certificate of compliance of the manufacturing conditions of medicinal products with the requirements of good manufacturing practice (GMP) or a conclusion on confirmation of compliance of the manufacturing conditions of medicinal products with the requirements of good manufacturing practice (GMP) in Ukraine on a turnkey basis as soon as possible!

Dmitry Vladimirovich Zadvorsky

Director

Dmitry Vladimirovich Zadvorsky
Director

The procedure for confirming compliance of the manufacturing conditions for medicinal products with the requirements of good manufacturing practice (GMP) may be based on the procedure for documentary examination of the applicant’s documents or, in cases provided for by law, an inspection of the manufacturer’s plant.

Inspection of the manufacture of medicinal products at the place of business, including contract laboratories, is carried out in the following cases:

if the applicant (applicant's representative) applies;

for non-residents who do not have official documents on the compliance of the manufacturing conditions for medicinal products with GMP requirements issued by an authorised body of an EU member state, the United Kingdom or a country that has a mutual recognition agreement with the EU or Ukraine;

in the absence of copies of marketing authorisations issued by the competent authority of the EU country whose authorised body has issued an official document on the compliance of the manufacturing conditions of medicinal products with GMP requirements, or issued by the competent authorities of other EU member states, the United Kingdom or countries that have a mutual recognition agreement with the EU or Ukraine.

How we work:

You send us a list of required documents by email

DOWNLOAD THE LIST OF DOCUMENTS

We conduct a technical examination of the documents and conclude a contract with you.

Based on the primary documentation provided by you, we develop a full package of documents, which we send to you by e-mail for signature.

Upon receipt of the full set of required original documents, in accordance with the legal requirements, we submit them to the State Administration on Medicines and Drugs Control for review.

We organise and accompany you at all stages of the procedure for confirming GMP production conditions (analysis of technical documentation; development of the necessary forms and documents, submission of documents, organisation of inspection of the production site, obtaining reports from the GMP centre and the Certificate/conclusion issued by the State Administration on Medicinal Products).

If you do not have a quality system in place at your production facility, we can build one for you and obtain a GMP certificate on a turnkey basis!

Call us, our prices will pleasantly surprise you!

Order a consultation
in one click

Order a consultation<br in one click

Difficulties faced by companies

If you try to go through the procedure on your own
or turn to incompetent intermediaries:

Errors in the received documents

Not just one-off document processing

Delaying the process

Bureaucratic attitude of civil servants

What makes us different from other consulting companies is that we:

What makes us different from other consulting
companies is that we

We are exclusively engaged in medical/pharmaceutical consulting and nothing else

We do not only issue licences, but can also help with the entire path of medicines trade:

More than

15 years on the market

More than

100 of all pharmacies in Ukraine

100%

guarantee

We are trusted by

How we work:

You call us or leave
a request

We get all the necessary documents from you

We are working

We provide a free consultation and agree on all the details and cost

Conclude a contract

How we work:

You call us or leave us a request

We provide a free consultation and agree on all the details and cost

We get all the necessary documents from you

Signing a contract

We are working

Our mission is to help those who
care about people's health

Our mission is to help those who care about people's health

Pharma-document team

Find out the cost and
terms in one click

Registration

Licensing

Other services

pharm-doc@ukr.net

Main / Other services / Obtaining a certificate / conclusion on GMP confirmation

Do you want to get a GMP certificate or confirm it in Ukraine?

Dmitry Vladimirovich Zadvorsky

Director

Dmitry Vladimirovich Zadvorsky Director

Inspection of the manufacture of medicinal products at the place of business, including contract laboratories, is carried out in the following cases:

if the applicant (applicant's representative) applies;

for non-residents who do not have official documents on the compliance of the manufacturing conditions for medicinal products with GMP requirements issued by an authorised body of an EU member state, the United Kingdom or a country that has a mutual recognition agreement with the EU or Ukraine;

How we work:

You send us a list of required documents by email

We conduct a technical examination of the documents and conclude a contract with you.

Based on the primary documentation provided by you, we develop a full package of documents, which we send to you by e-mail for signature.

Upon receipt of the full set of required original documents, in accordance with the legal requirements, we submit them to the State Administration on Medicines and Drugs Control for review.

Order a consultation in one click

Order a consultation<br in one click

Difficulties faced by companies

If you try to go through the procedure on your own or turn to incompetent intermediaries:

Errors in the received documents

Not just one-off document processing

Delaying the process

Bureaucratic attitude of civil servants

What makes us different from other consulting companies is that we:

What makes us different from other consulting companies is that we

We are exclusively engaged in medical/pharmaceutical consulting and nothing else

We do not only issue licences, but can also help with the entire path of medicines trade:

More than

15

years on the market

More than

100

of all pharmacies in Ukraine

100%

guarantee

We are trusted by

How we work:

You call us or leave a request

We get all the necessary documents from you

We are working

We provide a free consultation and agree on all the details and cost

Conclude a contract

How we work:

You call us or leave us a request

We provide a free consultation and agree on all the details and cost

We get all the necessary documents from you

Signing a contract

We are working

Our mission is to help those who care about people's health

Our mission is to help those who care about people's health

Pharma-document team

Find out the cost and terms in one click

Find out the cost and terms in one click

All services

Registration

Licensing

Other services

pharm-doc@ukr.net

Thank you, application has been submitted!

Dmitry Vladimirovich Zadvorsky
Director

Order a consultation
in one click

If you try to go through the procedure on your own
or turn to incompetent intermediaries:

What makes us different from other consulting
companies is that we

You call us or leave
a request

Our mission is to help those who
care about people's health

Find out the cost and
terms in one click

Find out the cost and
terms in one click

Thank you,
application has been submitted!