If you are seeking regulatory approval in Romania or require expert regulatory advice and support, 2AS are the regulatory affairs experts you need to talk to.

Founded in 2006 2AS has developed a comprehensive range of services to meet the rapidly changing demands for timely project completion, from strategic planning and expert advice to hands-on regulatory submissions:

• Preparation, submission and follow-up of marketing authorisation applications
• National, Decentralised and Mutual Recognition procedures
• Management of variations and renewals
• Liaison with Romanian Regulatory Agency
• Updating of dossiers from “old” to CTD format
• Preparation of Quality Overall Summary
• Translation of SmPCs, PILs and mock-ups from English into Romanian
• Comprehensive advice on regulatory matters
• Assistance with Regulatory Compliance, review of practice vs. approval
• Regulatory Training.

2AS offers exceptional regulatory professionals, comprising highly skilled, dedicated senior pharmaceutical experts with over 30 years experience available to suit your regulatory requirements.

Our experts are professional's choice for providing most optimal solutions for all kind of projects within the pharmaceutical industry.

Please do not hesitate to visit our website (http://2as.weebly.com/) and contact us directly if you feel we can be of any further assistance.