Product development consultation including gap analysis
Whether your objective is efficient and timely initiation of first-in-human clinical studies or a successful first-cycle marketing application, Dr. Mylecraine can assist you in design and execution of an appropriate testing program.
Scientific writing and regulatory dossier preparation
Dr. Mylecraine has authored and reviewed many regulatory documents. He is well experienced in preparation of written and tabulated summaries in eCTD format. He can prepare nonclinical parts of the following types of documents:
Regulatory Interactions
Dr. Mylecraine has particpated in many regulatory meetings. He can assist you in preparation for your meeting and, if desired, participate in the meeting. He can also help you prepare for public meetings, such as FDA Advisory Committee meetings, by serving as a mock panelist.
Peer review and editing of existing documents
As an alternative to 'ground-up' document preparation, Dr. Mylecraine can work with your internal documents, to save both time and money.
Briefing documents (meeting packages, advisory panels)
Regulatory submissions (eIND, IND, NDA, CTD)
Applications
for orphan drug and fast track status
Special protocol applications (carcinogenicity, pediatric)
Supporting documentation
(Investigator Brochures, expert reports)
Nonclinical reports and summaries
White papers
Services