Croma
CROMA is a regulatory affairs and market access consultancy specializing in European and local Greek and Cypriot healthcare regulations. With over 18 years of experience, they provide personalized, high-quality services to pharmaceutical, food supplement, medical device, cosmetic, and biocide companies, helping them navigate complex regulatory environments and achieve market access in Greece and Cyprus. Their mission is to be the first choice regulatory partner, offering expertise, integrity, flexibility, and quality in their services, and their vision is to be recognized as the most reliable and professional regulatory affairs partner in Greece and Cyprus.
Industries
Nr. of Employees
small (1-50)
Services
End‑to‑end preparation and electronic submission of marketing authorization and life‑cycle dossiers, including eCTD publishing and follow‑up with national authorities.
Preparation and negotiation of price and reimbursement applications and strategic market access planning for Greece and Cyprus.
Evaluation of ingredient permissibility, dossier preparation, Greek labeling creation, electronic notification and follow‑up with national authorities.
Preparation and submission of device registration/notification dossiers for distributors, manufacturers and EU representatives; assistance with national registry submissions and reimbursement listing.
Consultation and preparation of national biocide dossiers, online registration and submission of renewals and variations.
Local safety reporting, SUSAR/PSUR submissions and local QP support delivered through a partner pharmacovigilance provider.
End‑to‑end preparation and electronic submission of marketing authorization and life‑cycle dossiers, including eCTD publishing and follow‑up with national authorities.
Preparation and negotiation of price and reimbursement applications and strategic market access planning for Greece and Cyprus.
Evaluation of ingredient permissibility, dossier preparation, Greek labeling creation, electronic notification and follow‑up with national authorities.
Preparation and submission of device registration/notification dossiers for distributors, manufacturers and EU representatives; assistance with national registry submissions and reimbursement listing.
Consultation and preparation of national biocide dossiers, online registration and submission of renewals and variations.
Local safety reporting, SUSAR/PSUR submissions and local QP support delivered through a partner pharmacovigilance provider.
Expertise Areas
- Regulatory affairs for pharmaceuticals
- Market access and reimbursement strategy
- Electronic regulatory submissions and dossier management
- Medical device and in vitro diagnostic registration
Key Technologies
- Electronic dossier publishing (eCTD)
- National electronic regulatory submission platforms
- European device registration databases / registries
- Pharmacovigilance safety databases and reporting systems
News & Updates
20 Years of Successful Business
CROMA has reached 20 years of successful business, establishing collaborations with international companies and developing a quality management system certified by ISO 9001:2015.
20 Years of Successful Business
CROMA has reached 20 years of successful business, establishing collaborations with international companies and developing a quality management system certified by ISO 9001:2015.