our services
regulatory and scientific consulting
- regulatory advise and leadership on CMC, pre-clinical and clinical topics
- profound experience in all types of protein drugs (mAbs, fusion proteins, bispecifics, ADCs)
- expert knowledge in analytical comparability and similarity studies
- regulatory strategies and submission plans
clinical trial applications/INDs
- full IMPD preparation (quality, non-clinical and clinical sections)
- IND opening and maintenance
- coordination of CRO global submission activities
- response to deficiency letters/information requests
- regulatory review of IB, CSP/CSR, PSP/PIP, DSUR
- IMPD/IND amendments
program and project management
- management of international project teams from early development to approval
- setting up project plans, budgets and team structures
- project controlling
- management of CMOs/CROs
- contract negotiations
- technical and regulatory gap asssessments
- due diligence support
dossier preparation for global markets
- preparation of BLA/MAA dossiers for global submissions in highly regulated markets
- coordination of dossier authoring for all modules (1-5)
- scientific writing with focus on quality/CMC (m3 and m2.3)
- coordination of external eCTD compilation, formatting and publishing
scientific advice procedures
- authoring of briefing books for a wide range of meeting types
- FDA pre-IND, Type B/C and Type 1-4 BPD meetings
- EMA/CHMP scientific advice
- national health authority meetings (e.g. PEI, AGES)
- development of response strategies
- team coaching and on-site meeting preparation
post-approval and dossier maintenance
- regulatory support for various types of lifecycle management procedures
- preparation of variations (EU), prior approval supplements (US) and other post-approval dossier updates
- line extensions
- annual reports, PSURs
- product renewals
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