SERVICES
With core expertise in toxicology and regulatory affairs, MC Toxicology Consulting supports drug development by designing tailored, product- and indication-specific regulatory toxicology programs. The company offers services and solutions à la carte or
as part of an integrated program, defining innovative, non-standard pathways if warranted, and thereby directly responding to client needs.
Non-Clinical Drug Development
Our expertise in non-clinical drug development applies to known and novel entities in a broad variety of therapeutic fields including but not limited to oncology, auto-immune and inflammatory diseases, (rare) congenital diseases, infectious diseases,
dermatology, ophthalmology, and cardio-vascular diseases. In the following a selected list of previous activities and work packages is provided:
- Integrated planning and placement of regulatory toxicology studies in support of all stages of clinical development
- Development and placement of therapeutic product-tailored in vivo PK/PD studies, including biodistribution studies, in support of regulatory toxicology studies and clinical dose justification
- Development of fully comprehensive non-clinical development plans including regulatory strategy for Europe and US for small molecules, biologics, and ATMPs
- Quality control, including qualification audits of candidate CROs and study audits
- Project management of full non-clinical development programs or parts thereof
- Technical and strategic due diligence support for investors, strategic buyers, or asset acquisition for companies
Regulatory Consulting
Qualified and well-timed interactions with regulatory authorities are crucial for successful drug development. To follow standard requirements is often a good choice – but sometimes of no scientific value. Deviating from standard requirements requires
significant experience and innovative, science-based approaches. MC Toxicology Consulting has an extensive track record with the following activities:
- Advice on appropriate regulatory strategy (timing, focus, content,) with EMA, (national) European regulatory authorities and the FDA
- Implementation of regulatory strategy including (but not limited to): preparation and submission of Scientific Advice and Protocol Assistance, pre-IND and End of Phase II packages (focus on non-clinics)
- Support and facilitation of specific regulatory interactions with various EU and US authorities in support of first-in-human studies – including compilation and submission of supporting documentation, IB, IMPDs, INDs, etc.
- Continued authority interaction around non-clinical topics to facilitate later stage clinical development and marketing authorization application
- Addressing specific toxicology issues raised by regulatory agencies
- Certification procedure for ATMPs
Toxicology Evaluation
Areas of technical expertise include genotoxicity, carcinogenicity, reproduction and developmental and juvenile toxicity, neurotoxicology, immunotoxicology. In the following a selected list of previous activities and work packages is provided:
- Customized, non-clinical study design and protocol development for pilot and pivotal safety studies of drug candidates, including the selection of appropriate animal species
- CRO selection, study placement and monitoring
- Interpretation of toxicology findings including histopathology in context of the target indication and population – benefit / risk evaluation
- Evaluation and integration of toxicokinetic results into the overall toxicology data package
- Definition of human starting and therapeutic dose based on NO(A)EL/MABEL
- Support in method development for GLP (bio)analytics plus selection of non-clinical and (bio)analytical CROs
- Assessment and advice in case of changes to manufacturing process / comparability exercise
- Smart design of drug candidate screening programs
Product Types
We have a proven track record with various product types.
- Biologics including monoclonal antibodies, proteins, peptides, biosimilars
- ATMPs / GCTs including CRISPR/Cas-edited cells, vector-based products and stem cells
- Oligonucleotides (RNAs, DNAs)
- Therapeutic and prophylactic vaccines
- New adjuvants and lipid nanoparticle formulations
- Herbals
- Combination products
- Nanoparticle formulations
- Cosmetics and borderline products
Project Management
MC Toxicology Consulting offers full project management and in select cases project leadership support for non-clinical development programs or parts thereof. Our approach here is to take responsibilities and not neglect interfaces. We prepare and lead
streamlined decisions and development processes aiming for shortened timelines. We always aim at the optimization of program timelines without compromising on quality and development risks.
- Project management for virtual start-up teams; full project infrastructure in pre-clinical phase, including manufacturing, non-clinical studies, bioanalytics
- Project infrastructure for science-based early development collaboration, including transition to development-driven project management
- Project coordination for regulatory advice-driven early development phase
Scientific / Regulatory Writing
We offer scientific writing services for the following document types.
- Data analysis, research report writing and review
- Publications in peer-reviewed journals
- Briefing Dossier preparations for European National Advice Meetings, EMA and FDA Meetings
- IB, IND preparation, review, filing and maintenance
- CTD and Certification Dossier preparation (Modules 2.4, 2.6 and 4) for NDA, BLA, and MAA filing.
- Scientific review of marketed materials
- Set up of documentation system
- SmPCs