Asphalion’s team has academic research experience and broad scientific background in the area of nonclinical, clinical medical and CMC writing for Innovative, Biological, Biotechnological, and Advanced Therapy Medicinal Products, including gene and somatic cell therapies.

We can elaborate all regulatory documentation required during development and registration. Likewise, existing documentation can be assessed and completed by our team of experts.

• Common Technical Dossier (CTD): preparation of complete dossiers ready for registration procedures, including expert’s signature.
• Gap analysis and update of CMC, non-clinical and clinical sections.
• Technical documentation: scientific reports.
• Readability tests for all types of EU registration procedures.
• Transparency (Policy 0070) compliance: documentation masking, anonymization reports.
• Entry data in EudraCT (Europe) and clinicaltrials.gov (FDA)
• Writing for all types of products and therapeutic areas. Strong expertise with innovative NCEs, ATMPs, Biologicals and Biosimilars.

We have compiled multiple CP, IND, NDA dossiers and prepared more than 25 IMPDs / IBs. We have strong expertise with ATMPS, Biologicals and Biosimilars, including the writing of full CTD dossier for a biosimilar Centralised Procedure.