Through our Regulatory Affairs Department, entered into service in 2007,  we provide consultancy services and support to our national and international clients in the registration process of pharmaceuticals (generics, originals and borderline products), OTCs, medical devices, cosmetics and food supplements in all fields, including pricing and reimbursement. In this context, we prepare registration application dossiers, ready to submit to the Agency, for original and generic human medicinal produıcts as well as borderline products and medical devices.

We work with an outstanding service approach, with a dynamic and well-trained RA expert team, who has vast experience and knowledge.

Our References are;

• PRS Clinical, USA

• Insight Agents, Germany

• Dr. Regenold, Germany (Long-time consultancy and regulatory affairs services regarding the preparations of EU e-CTD submissions are given.)

• IWA Consulting Aps., Denmark (Long-time consultancy and regulatory affairs services regarding the preparations of EU e-CTD submissions are given.)

• Tarius A/S, Denmark (Summary Reports for Medical Devices and Pharmaceuticals has been prepared for Turkey and they are updated in a monthly basis)

• Alcon, Turkey

• Alfa Wasserman, Turkey

• Apotex, Turkey

• Astellas, Turkey

• GSK, Turkey

• Solvay, Turkey 

With the help of international regulatory affairs networks, FarmavitaR (www.farmavita.net) and Regulanet (Network of Regulatory Affairs Agencies, www.regulanet.com), which we affiliated with, and the eCTD Docubridge software that we use, we prepare registration application dossiers (CTD, eCTD and electronic applications) for generic, original and OTC products for all EU member countries, USA and Canada as well.

Our program, LORENZ Life Science Group’ product Docubridge (www.lorenz.cc)  has evolved to become the world’s most advanced, comprehensive and successful CTD-eCTD Submission Management System (SMS) with 20 years of unquestionable regulatory experience.

 By its adaptable architecture, Docubridge can work with any kind of standard (CTD, eCTD, NDA, etc) applied in the past, now in force and will be applied in future.

The list of services we provide within the scope of Regulatory Affairs;

• Pre-submission assessments

• Preparation of the local documentation for the national registrations (CTDs)

• Translation of the technical documentation

• Post-licensing advice; variation and renewal applications

• Preparation of SPC and PIL

• Monitoring 

• Reporting 

• Providing update legislative information

• Advice on pricing / reimbursement policy / reimbursement dossier preparation

• Organization of meetings with the Client and the Competent Authority, assist the Client during the meeting

• Advice on the requirements of labeling based on the national legislative