RUJNER.EU

Regulatory

• Consulting in the area of Regulatory Affairs.

• Planning of regulatory strategies, assessing regulatory compliance

• Experience of the submission process as DCP, MRP, CP.

• Regulatory assessment of amendments, preparation of the necessary documentation, implementation of the process with respect to regionalrequirements.

• Coordinate documents for product registrations and registration renewals

• Collection and preparation of submission documents (technical documentation files, dossiers)

• Identify required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines.

Quality product and development 

• Review and approval of scientific documentation for quality related Regulatory Affairs activities

• Coordination and preparation of response documents to regulatory authorities

• Performance and monitoring of stability studies, assessment of results as well as establishment of stability reports.
• Organization of analytical method transfers to Quality Unit, CROs, etc. including preparation of protocol and report.

Compilation (resp. close cooperation with registration department) of relevant documentation (e. g. control procedures, risk assessments, development report).