ABOUT HOCHOKTAN
With comprehensive experience in drug development aiming for a specific target product profile, I design development plans tailored to every client’s specific needs.
WHY CHOOSE HOCHOKTAN?
I provide effective solutions based on a deep understanding of prior clients
As the regulatory affairs expert i am dedicated to work in close collaboration with you as client to ensure the confidential disclosure agreement (CDA) is signed prior to proprietary knowlegde being shared with service providers, ensure the
request for proposal contains all required information for a clinical or commercial application through to manufacturing for commercialization as well as global registration support and maintenance.
Services
Regulatory Affairs CMC advice for CDA and proposals
Knowing the current and upcoming changes to the legislation and guidelines is paramount to drug developement. 20 years of experience in Regulatory Affairs have shown how being on the forefront ensured that delays can be avoided with forward planning.
Technical CMC writing and review (gap analysis)
Knowing the little details required before the health authorities asks for them gives trust (and less scrutiny). Being able to write with just sufficient detail and not investing money in data being generated to early will ensure you as client can prioritise.
Scientific advice and regulatory Affairs interpretation
knowing how to set up the meeting, write the minutes for those authorities required this and prepare the briefing book is of most importance.
- Regulatory Strategy & Gap Analysis— global & local market entry plans, orphan/accelerated pathways
- eCTD & Publishing— authoring, publishing, validation, lifecycle variations
- CMC Authoring— modules 2 & 3, DMF/CEP support, stability strategies
- Labeling & Artwork— multi-region labeling, translations & controlled change management
- Regulatory Intelligence & RIM— dossier tracking, submission calendars, regulatory change alerts
- FSP & Resourcing— dedicated teams, time & material, and outcome-based models
- Pharmacovigilance interface— safety reporting handovers and aggregate reporting support
- HTA & Reimbursement support— dossier alignment and evidence packaging
