Services

WHAT WE CAN OFFER YOU

Although the registration procedures for obtaining Marketing Authorization of medicinal products in each EU country are harmonized, there are still very important local barriers that have to be passed for obtaining access of your products into each market.
Those barriers include pricing and reimbursement criteria, hospital formularies, delays in the issuing of licenses, regulations on promotional expenses and a number of other measures that are taken in national level by the government in order to contain the increasing pharmaceutical bill.
We have deep knowledge of the Greek Healthcare Environment, excellent relations with key stakeholders and good understanding of the inner working of the Greek Health Authorities.
You can find in us the partner that in collaboration with you can break these barriers enabling the ACCESS OF YOUR PRODUCTS INTO THE GREEK MARKET.

We will work with you as follows:

We will listen and understand your needs
We will give you valuable information on the Greek Health environment making you understand the localbarriers and requirements.
We will review your data and collaborate with you in making the business plan to be followed, including:
- The strategic decisions to be taken based on realistic assumptions on timelines and expected outcomes
- An implementation plan according to agreed timelines
During our collaboration we will provide you reports on the progress of the project in a regular basis
We will proactively take measures to avoid issues, especially those that can be predicted.
We will resolve any unpredictable problem that could raise during the implementation phase.
Finally we will offer you our services in a reasonable cost.

Please use the link to see the services we provide:

SERVICES

Croma is providing its services listed below, working personally and closely with its partners striving to achieve best results in relation with set priorities and time frames.

CROMA’s services include:

Presubmission advice throughout the submission stages (Mutual Recognition, Decentralised and Centralised procedure, National Procedure) for Greece and Cyprus, pricing, reimbursement, but also for the strategy to be followed for the fast and safe access of your products in the Greek Market.

Submissions to Regulatory Authorities
Negotiations and influencing activities to Regulatory Authorities
Pricing submissions and negotiations with the Ministry of Development
Reimbursement negotiations and inclusion of pharmaceutical products in the reimbursement lists
Labelling preparations
Clinical Trial Applications
Pharmacovigilance
Promotional Materials compliance to national legislation and to local Code of Practices.