Registration of medicines without difficulties

The guarantee of your success

On the Ukrainian market - since 2019

DIRECTIONS OF WORK

We work in the following areas:

01.

Registration of medicines

Amila Health Kea LLC provides a full range of services for the registration of medicinal products in Ukraine and abroad.
We support the process from the preparation of documents in eCTD format to obtaining a registration certificate, ensuring compliance with the requirements of the SEC and international regulatory authorities.
Our experience, professional approach and attention to detail allow partners to quickly and efficiently bring products to the market, while maintaining quality and compliance with high standards.

02.

Pharmacological supervision

Patient safety is our priority.

Ensuring the safety of medicines is an integral part of your business.
Insufficient control or the absence of a pharmacovigilance system can lead to serious consequences: from loss of reputation to legal problems.

Our company offers a full range of pharmacovigilance services so that you can be confident in the safety of your medicines and the trust of your customers.

03.

Scaling your business

Scaling your business is a new level of opportunity. We help companies open new markets, increase profitability, and strengthen their competitive advantage.

Our solutions combine strategy, innovation, and practical experience to help your business grow faster and more confidently.

Let us take care of all the routine. We are your trusted partner in medical record registration, freeing up your time and resources for what matters most: growth, innovation, and scaling.

WE WORK FOR YOU

We provide the following services:

Our company provides a full range of services to support and accompany the state registration and re-registration of medicinal products. Our team, consisting of experienced specialists, takes care of all the work with documents, ensuring compliance with legislative requirements.

Our services include:

consultations and assistance in preparing the registration dossier;
preparation of cover letters and responses to comments;
translation and copying of necessary documentation;
preparation of a registration application and conclusion of an agreement with the State Expert Center (SEC);
monitoring the registration process and constantly informing the client about its progress.

We make every effort to significantly reduce the time frame and ensure the successful completion of the drug registration procedure for our clients.

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COOPERATION

How we work with clients

Preparation of a package of documents

Meeting with a specialist, signing a contract

Payment for work performed

Why choose our company?

Our company is a team of experts that has been successfully assisting clients in the complex processes of state registration and re-registration of medicinal products for many years. We have in-depth knowledge of legislative requirements and the intricacies of regulatory procedures. This specialization allows us to effectively resolve any issues that may arise and ensure a successful outcome.

Reliability

Our organization has established itself as a reliable and stable partner

Quality

We combine quality services and a deep understanding of the law

Результат

We don't just do the job, we provide you with comfort and confidence at every stage of cooperation.

Any questions left?

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PROFESSIONALISM

We are a team of highly professional specialists

Amila Health Care offers full support services for the registration of medicinal products in Ukraine. Since this process requires a deep understanding of legislative norms and specific requirements, we recommend entrusting the preparation of documents to our experienced lawyers to avoid potential problems and delays.

The key to achieving the desired result!

Our company’s specialists will provide you with expert advice on any issue that interests you.

Experienced specialists
Speed and reliability
Comprehensive approach

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