Stark Associates provides strategic consulting for various processes of the life sciences regulatory domain and we support leading life science companies in the development of high-quality regulatory documents for Europe, US, Middle East, Africa and other emerging markets with a strong regulatory team experienced in scientific research and clinical practice.
Regulatory Affairs
- Clinical Trial Application Dossiers
- Compile Dossiers for New Product Launch
- CMC Change Controls and Variations
- Investigator Brochures (IB), Informed Consent Forms
- Clinical Study Synopsis, Protocols and Amendments
- Clinical Study Reports (CSRs); Phases I to IV and BA/BE
- Clinical Trial Registries and Results Disclosure
- Drug Master File (DMF) & Investigational Medicinal Product Dossier (IMPD)
- SAE reports for Health Authorities and IRBs Submission
- Company Core Data Sheet (CCDS)
- Summary of Product Characteristics (SmPC)
Regulatory Publishing
- Publishing Services (eCTD, NeeS, Paper)
- SPL Submission Services
- Artwork Services
- Product Lifecycle Management
Artwork Labelling
- Design of art-work labels
- Local Product Labels
- Patient Leaflets, Inner and Outer Package Labels
- Product Information File (PIF), SPL creation
Regulatory Intelligence
- Regulatory Strategic Planning for New Product Development and Launch
- New Market Regulatory Strategy Intelligence
- Specialized Strategic Planning for Fast Tracked and Orphan Products
- Access, Summarize and Assess Global Regulatory Intelligence
Medical Device
- PMA, 510 (k) and HDE submissions
- Implementation of Unique Device Identification(UDI)
- EU MDR Compliance & Transition
- AE processing and Product Quality Complaints
