Execution of the parts of the registration procedure: 

1. Preparation (localization) of the dossier:

1.1. Translation of the medical and chemical documentation.

1.2. Translation and preparation of the AND (Analytical Normative Documentation).

1.3. Translation and preparation of the TND (Technological Normative Documentation).

1.4. Translation and preparation of the instruction and leaflet.

1.5. Preparation of the package design.

1.6. Translation, editing and summarizing of the expert reports.

1.7. Preparation of the dossier from A to Z.

2. Registration of the product in the SPhC MOH Ukraine.

2.1. Submission and accompanying of the dossier in Pharmacological Center.

2.2. Import of the samples.

2.3. Solving different problematic issues.

Many companies, that have a Regulatory affairs department in a local Representative office, in the moments of heavy duties, transfer some responsibilities for preparation of the documentation or other components of the registration procedure to us. We are always ready to provide you with our knowledge and experience for finding the fast solutions of the complicated issues or act as your assistant, consultant.

Our team includes medical doctors, chemists-analytics, technologists, clinicians that have a really significant experience in registration of the medicinal products in Ukraine .

For every inquiry for our service we develop the separate strategy of the cooperation, but in general our services in execution of separate specific parts of the registration procedure can be divided into two parts - (1) preparation (localization) of the dossier and (2) submission and accompanying of the dossier.

1. Preparation (localization) of the dossier:

1.1. Translation of the medical and chemical documentation.

We have highly qualified translators in our staff that can quickly perform the quality translation of the technical text from English to Russian/Ukrainian, and in reverse. We also have an employees that can perform the professional quality control of the translated text.

Price – from 5 EURO for 1 conditional page (1800 symbols).

1. 2. Translation and preparation of the AND (Analytical Normative Documentation).

Chemist-analytic of Cratia Ltd. will prepare the AND upon control methods of the manufacturer, in accordance with all current requirements of the Ukrainian legislation. We take the responsibility (included to the fee) to handle all the following questions of the State Pharmacological Center and state laboratory related with prepared document.

Price – from 350 EURO.

List of required documents: Specification, certificate of analysis on the finished product, initial control methods of the manufacturer.

1.3. Translation and preparation of the TND (Technological Normative Documentation).

Technologist of Cratia Ltd. will prepare the TND in accordance with description and validation of the manufacturing process, in accordance with all current requirements of the Ukrainian legislation and requirements of the State Authority of medicinal products and medical devices. We take the responsibility (included to the fee) to handle all the following questions related with prepared document.

Price – from 300 EURO.

List of required documents: description of the manufacturing process, validation of the manufacturing process, manufacturing scheme.

1.4. Translation and preparation of the instruction and package leaflet.

Instruction for medical use and package leaflet will be prepared by doctor of the respective specialization upon initial documentation of the manufacturer (Summary of product characteristics, Core data sheet). We take the responsibility (included to the fee) to handle all the following questions related with prepared document.

Price – from 150 EURO.

List of required documents: SmPC/CDS/PL, clinical studies data.

1. 5. Preparation of the package design (box, blister).

Experts of Cratia Ltd. will prepare the package text upon initial package design, in accordance with requirements of Ukrainian legislation. We can also perfrom changes in the technical graphic files of Corel Draw (.crd), Adobe Photoshop (.psd), Adobe Acrobat (.pdf). We take the responsibility (included to the fee) to handle all the following questions related with prepared package design.

Price – from 50 EURO.

List of required documents – initial package design.

Important: we do not work (edit) the IBM Macintosh files.

1.6. Translation, editing and summarizing of the expert reports on clinical, pharmaco-toxicological (preclinical), chemical-pharmaceutical (pharmacological development) documentation in accordance with requirements of the Ukrainian legislation and field standards. We take the responsibility (included to the fee) to handle all the following questions related with prepared documents.

Price – from 300 EURO.

List of required documents: initial reports in English, 3 and 4 parts of the dossier in “simple” or Module 4 and 5 in CTD format.

1.7. Preparation of the dossier from A to Z.

In accordance with received from manufacturer documentation, experts of Cratia Ltd. will prepare the list of missing documents and prepare the letters with questions to the manufacturers, prepare the Application, translate the required parts of the dossier, prepare the AND, TND, instruction for use and leaflet, table of contents, cover letter. Finished product – is a dossier in a hard form that is ready for submission plus CD-disc with the text of the prepared and translated documents. We take the responsibility (included to the fee) to handle all the following questions related with prepared documents.

Price for preparation of the dossier – from 1500 EURO.

List of required documents: in accordance with requirements of the Order №426 – dossier in “simple” or CTD format.

2. Registration of the product in the SPhC MOH Ukraine .

2.1. Submission and accompanying of the dossier in Pharmacological Center .

In the case, is experts of the Applicant will prepare the dossier by themselves that is ready for submission to the State Pharmacological Center – we can take responsibility for it's submission and accompanying. These services include: control of the dossier for compliance to the requirements of the legislation, submission of the Application and dossier, everyday monitoring of the letters in the State Pharmacological Center, control of the terms of the expertise's, preparation and submission of the answers for questions, sending the documentation via world courier services etc.

Price for submission and accompanying the dossier “from A to Z” – from 1 5 00 EURO.

List of documents – localized dossier in “simple” or CTD format.

2.2. Import of the samples.

For quality assurance in the local laboratory – import of the specified quality of the samples of finished product, regents, active substance and reference standards is required. Experts of Cratia Ltd. will receive from laboratory conclusion about required quantity of samples, will receive the approval from import from SPhC of MOH of Ukraine, coordinate the accompanying custom documentation with manufacturer. Custom broker of Cratia Ltd. will perform the custom clearance of the freight and deliver it to the laboratory.

Cratia Ltd. can receive freight on it's own name since we are have accreditation in the Kiev regional and Boryspil customs.

Price of our services for import of the samples – from 250 EURO.

List of required documents: AND or conclusion of the laboratory regarding quantity of the samples required, CoA on all samples/standards/regents.

2.3. Solving different complicated issues .

During registration of the medicinal product in Ukraine many different complicated questions and situations can appear, such as specific questions of the profile commissions of the SPhC of MOH, import of the narcotic or hazardous products (finished products or regents, substances), vagueness in requirements of some specific legal acts and so on. Expert of Cratia Ltd. have the great experience in solving different situations, have an access to the legislation of the European Union and USA and well-experiences in treatise of the local laws.

Price of our services depend on the complicity, specificness and amount of the expected work.

If you are interested in services of our company in the field of State registration of medicinal products, you can also find at our website:

• commercial offer for registration of the medicinal product;

• detailed information about renewal of registration of medicinal product;

• detailed information about implementing changes (variations) to the registration certificate;

• contact us;

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