Products & Services Offered:

Regulatory strategy

Regulatory submissions:

·  Clinical Trial Applications

·  Marketing Authorization Applications

·  Renewals

·  Variations

Pharmaceutical writing / CMC documentation:

·  CTAs/INDs

·  Scientific Advice: Briefing books

·  Marketing authorization applications, Variations, Renewals:

   CTD Modul 3, Quality Overall Summaries (QOS)

·  Review and gap analysis of CMC documentation

·  Stability/Analytical Reports

·  Scientific translations: German - English, English - German,

   Swedish -English, Swedish - German

             Medicinal products covered:

            ·  NCEs, Generics

            ·  Biologicals, Biosimilars

            ·  Advanced Therapies Medicinal Products (ATMPs)