Croma - Regulatory Affairs and Market Access Partners in Greece

Croma was established after long and extensive experience in regulatory affairs and market access issues, working in leading positions in big multinational pharmaceutical companies such as AstraZeneca, Bayer and Sandoz.

Croma has the ambition to provide to our partners the best support in driving their products quickly, safely and effectively into the Greek market.

Regulatory affairs for pharmaceutical business

We believe in the strategic importance of regulatory affairs for the success of the pharmaceutical business, and in the demanding and constantly changing health environment at both European and local level.

We understand that market access is the critical success factor, as a result of a long chain of approval procedures that have to take place before launching your products into the Greek market.

Marketing authorization of medicinal products

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 at 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.

Introduction and marketing of medicines in Greece

Croma offers the following services:

• We will be dedicated to your company, providing personalized services
• We will listen to and understand your needs
• We will give you valuable information on the Greek health environment, making you understand the local barriers and requirements

Croma 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 with 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 arise during the implementation phase
• We will offer you our services at a reasonable cost

Croma provides the services listed below, working personally and closely with its partners and striving to achieve the best results in relation of 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 and the strategy to be followed for the fast and safe access of your products into the Greek market
• Submissions to regulatory authorities
• Negotiations and influencing activities to regulatory authorities
• Pricing submissions and negotiations with the Greek ministry of development
• Reimbursement negotiations and inclusion of pharmaceutical products in the reimbursement lists
• Labeling preparations
• Clinical trial applications
• Pharmacovigilance
• Promotional materials' compliance to national legislation and to the local code of practices