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:

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:

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:

Product Types

We have a proven track record with various product types.

Risk Assessment / Other

MC Toxicology Consulting has performed numerous risk assessments on various substances. In the following a selected list of previous activities and work packages is provided:

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.

Scientific / Regulatory Writing

We offer scientific writing services for the following document types.