Medical and Scientific Writing

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.

Support as Scientific and Medical Writers for CTD, Technical Documentation and Other Procedures​

At Asphalion, we know the requirements that the documents must meet in order to be approved, especially if they are dossiers for registration procedures such as CTD, technical documents for scientific reports or are transparency compliance reports. Therefore, as your partner, we cover the following procedures:​​

• 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.