Alhena Consult is a consulting firm in regulatory affairs and drug development. We help start-ups reach first-in-human administration (Phase 1/POC) by ensuring that regulatory requirements in pharmaceutical, non-clinical and clinical settings are taken into account.
We help to develop the development plan, advise in the selection of CROs for NC, clinical studies and CDMO for the active and finished product. With extensive experience in CMC topicals, we are also comfortable with the formula and expertise of the CMC file. We write the pharmaceutical dossier for submission (IMPD) and help with the other documents. We provide strategic but also operational support, working with the customer as a team for the patient.
All of the consultants at Alhena have experience in the pharmaceutical industry and half have worked in dermatology for leading dermatologists. Since our creation, we have worked with several companies and on several projects in dermatology, on NCEs but also with biologics, and on topical or sterile injectable products