MEDICAL WRITING

SmPC / PIL

Readability User Tests

PSUR

Environmental Risk Assessment and Risk Management Plans

Non-Clinical and Clinical Overwiev and Summaries

etc.

 

PRE-SUBMISSION ASSESSMENT

Full Dossier Assessment and GAP Analysis

Assessment of Old Dossiers, Gap Analysis, Update of Dossier to be Compliant and Ready for Submission

Converting Regulatory Documentation into eCTD/NeeS Format

Strategical Regulatory Advice

Product Concept Identification

National Legislation Interpretation

Market Access Strategy Development in Early Phases

External Resource/Expert Management

etc.

 

SUBMISSION

GMP Audit Support

Dossier Preparation (CTD, eCTD)

Translation Services

Submission Processes (Marketing Authorization Applications, Procedural Management)

Liasion with Health Authorities

 

POST-AUTHORIZATION ACTIVITIES

Post-Authorisation Maintenance and Support Through Effective Life Cycle Management

Change Control Assessment and Variation Management (type IA, IB, II);

Marketing Authorization Renewal Management

MA Transfer Management

Preparation of Responses to Regulatory Agencies Questions

Dossier Amendment and Supplementation

Other Technical Expert Services

Labeling Support

SmPC/PIL Amendments

Product Line Extensions

Product Status Change

Advertising and Promotional Material Review

etc.

 

OTHER ACTIVITIES

Marketing Authırization Holder Service

Pharmacovigilance, and PSURs

Pricing Submissions and Management

Reimbursement Submissions and Management

Product Analysis Support

GMP Audit Support

Priority Applications

Outsourced Regulatory Affairs Department

Training

etc.