Registration of medical products and pharmaceutical substances
We offer our clients full maintenance of the procedure of registration of medical product or pharmaceutical substance, from the moment of primary expertise of registration file till the receipt of the original certificate of MH of Ukraine about product registration.
The process includes the following stages:
| 1st stage | Primary consultation of the client on procedure. |
| 2nd stage | Pre-expertise of the clients’ document package. |
| 3rd stage | Concordance of terms and conditions of registration procedure. |
| 4th stage | Execution of the agreement with SEC (State Expert Center). |
| 5th stage | Execution/presentation of the offer for registration to MH of Ukraine. |
| 6th stage | Execution/presentation of micro file for medical product to SEC. |
| 7th stage | Maintenance of the expertise micro file for medical product. |
| 8th stage | Payment of bills (SEC expertise services+ governmental charge). |
| 9th stage | Preparation for presentation/presentation of registration file in CTD format as a unit, corresponding to the specified expert committee. |
| 10th stage | Maintenance of state expertise of the file in the committees. Development of expert’s remarks. |
| 11th stage | Meeting at SEC on the matter of medical product registration. |
| 12th stage | Receipt/reading of registration documents project. |
| 13th stage | The order of MH on medical product registration. |
| 14th stage | Receipt of the originals of registration documents. |
8L GROUP – is a reliable and prompt registration of medical products and substances.
Please, contact us and we’ll help you to save your time and budgets for new opportunities.