Services
The registration of medicinal products
Medicinal products include the following types:
- finished medicinal products;
- immunobiological products;
- in-bulk products;
- active pharmaceutical ingredients (APIs).
Checking whether the registration dossier complies with the legislative requirements;
Preliminary consultations with the competent authorities;
Translation of scientific, medical, technical and legal documents;
Legal analysis and preparation of administrative documents;
Preparation of specific national documents: NTD, Pack incert, labeling of the packaging materials and layouts;
Preparation of the Application and registration form, collection and compilation of the registration dossier according to all requirements and recommendations;
Creation and maintenance of the pharmacovigilance system in Ukraine;
Development of the documents in the pharmacovigilance system;
Outsourcing the contact person responsible for pharmacovigilance in Ukraine;
Outsourcing the contact person responsible for the quality, safety and efficacy of the medicinal product in Ukraine;
Preparation and submission of the Application, registration form and registration dossier to the SEC of the MOH of Ukraine;
Organization of all payments and receiving the payment confirmation;
Support of expert evaluation process, communication with competent authorities;
Analysis of observations, preparation of recommendations to respond the observations;
Obtaining permission to import samples and standards for the quality control within registration;
Import (customs clearance) of samples and standards;
Control of deadlines at all the stages of expert evaluation;
Verification of drafts of the Registration Certificate and its Addendum;
Preparation of the Application and documents for obtaining the Conclusion or Certificate of compliance of the medicinal products conditions requirements. manufacturing with the GMP
Call us today for free consultations
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- +1 910-626-85255
Let's Find You Together the Place You Deserve
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services
- Registration of pharmaceutical products
- Registration of food preparations / dietary supplements and medical devices.
- Pharmacovigilance
- GMP
- TM registration services
- Monthly reports
Adress
-
Ukraine
Kyiv, 04050
Herzen Street, 17-25 -
Office:
Ukraine, street Oleksandra Myshuhy 2, office 418 - +38 (067) 236 70 30
- larysa@solutionsukraine.com
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