SAPIENTIS

WE WORK FOR YOUR COMFORT

SAPIENTIS

WE WORK FOR YOUR COMFORT

ABOUT US

LEARN ABOUT US MORE

Our team of professionals, sharing the same values, was created with the purpose of providing legal support to businesses and manufacturers in the pharmaceutical industry. Our fundamental principles include consumer orientation, individual approach, creation of benefits and long-term relationships. Having many years of experience, we will develop the best strategy to meet your needs.

Considerable experience of our team in such areas as registration/reregistration/amendment of registration dossiers of the pharmaceutical products, certification of medical devices, legalization of dietary supplements, baby food, registration of imported beauty products, certification of pharmaceutical products manufacturing, trademark registration, patenting of inventions, etc. ensures that we will be able to make your work significantly easier, save your time, money and take on a considerable amount of your urgent work with a guarantee of a successful result.

OUR SERVICES

OUR PROPOSALS

REGISTRATION

Registration

Registration / re-registration / variations of the registration dossier

Мanufacturing authorization (Registration certificate) for a registered / re-registered pharmaceutical products; changes to the registration dossier.

Сontinue

Legalization of imported beauty products

Conclusion and Appendix to the Conclusion of the State Sanitary and Epidemiological Expertise. Report on research work. Approved text for product labeling.

Сontinue

Legalization of dietary supplements, baby food

Conclusion and Appendix to the Conclusion of the State Sanitary and Epidemiological Examination. Report on research work. Approved text for product labeling.

Сontinue

Certification of medical devices

Declaration of Conformity with Annex / Certificate of Conformity / Entry of Information into the Register of Persons Responsible for Putting Medical Devices into Service.

Сontinue

MARKET SURVEILLANCE

Market supervision

Compliance with the requirements of quality and safety of medicines during circulation

Permission for circulation of medicinal products, introduction of appropriate changes in the database of the State Service of Ukraine for Medicinal Products and Drug Control.

Сontinue

Development and approval of the quality certificate template for the manufacturer

Certificate of quality analisis of a pharmaceutical product in accordance with the requirements of the legislation of Ukraine

Сontinue

Implementation of packaging in the process of manufacture

Permission for circulation of packaging in the territory of Ukraine

Сontinue

Pharmacovigilance

Positive opinion of a specialized examination of a medicinal product for pharmacovigilance, audit, etc.

Сontinue

CERTIFICATION

Certification

Changes to the list of medicines for registration in Ukraine

Updated list of medicines registered or scheduled for registration in Ukraine (in addition to the GMP Opinion)

Сontinue

Expanding the list of medicines for registration in Ukraine

Updated list of medicines registered or scheduled for registration in Ukraine (in addition to the GMP Opinion).

Сontinue

Certification of pharmaceutical products manufacturing

GMP Compliance Statement with a List of Medicines Registered or Scheduled for Registration in Ukraine (GMP)

Сontinue

Recognition of EC Certificate of Conformity of GMP

Recognition of EC Certificate of Conformity on compliance

Сontinue

OTHER SERVICES

Other services

Patenting inventions and utility models in Ukraine and abroad

Patent for Inventions and Utility Models in Ukraine and Abroad.

Сontinue

Trademark research in Ukraine and abroad

Trademark information in Ukraine and abroad

Continue

Medical translation: technical. documentation, manuals, licenses, GMP certificates

Medical translations: technical documentation, instructions, licenses, certificates and more

Continue

Trademark registration in Ukraine and abroad

TM in Ukraine and abroad

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ADVANTAGES

WHY SHOULD YOU CONTACT US

Guarantee of result

Professionalism and the optimal solution of the tasks set is our credo

Individual approach

A thorough study of your needs and the protection of your interests under the law

Transparency

Understanding each stage and reporting throughout the collaboration

Convenience

Save your time and expenses

REVIEWS

ABOUT US