Our CMC Development Solutions applies scientific and regulatory excellence to ensure optimal development of your drug candidate, from lead selection through preclinical, phase I and phase II.
At CMCAssist, we specialize in CMC consultancy, offering expert guidance on regulatory documentation, formulation development, and comparability assessments.
Timelines: We specialize in developing precise and efficient CMC timelines, ensuring your product development stays on track and meets regulatory milestones
Manufacturing: Our team provides strategic guidance on manufacturing processes, optimizing production efficiency, and ensuring compliance with industry standards
Formulation Patents: We provide specialized guidance on securing formulation patents, helping you protect your innovative drug compositions and delivery methods to ensure market exclusivity and competitive advantage
IMPD: We prepare thorough and compliant IMPD documents, facilitating smooth regulatory submissions and approvals within the European Union
IND: Our team offers strategic guidance and meticulous preparation of IND applications, ensuring successful submissions to the FDA and timely initiation of clinical trials
Briefing Documents: We provide expertly crafted briefing documents for regulatory meetings, helping you effectively communicate your development strategies and address regulatory concerns
Preformulation & Characterization: We conduct thorough preformulation studies and analyses to understand your drug's physicochemical properties
Comparability & Stability Studies: We execute comparability and stability studies to assess product changes over time, ensuring consistency and regulatory compliance
Toxicology & Clinical Formulation: From preclinical toxicology studies to clinical trials, we specialize in formulating drug candidates for both stages, ensuring safety, efficacy, and regulatory compliance throughout the drug development journey
Welcome to CMCAssist, a premier CMC consultancy dedicated to guiding pharmaceutical and biotechnology companies through the complexities of drug development. Our expertise spans CMC strategy, CMC writing, and CMC development, ensuring your projects progress smoothly from concept to market.
We develop robust CMC strategies, providing detailed timelines, optimizing manufacturing processes, and securing formulation patents to protect your innovations. Our skilled writers craft high-quality regulatory documents, including IMPDs, INDs, and briefing documents, ensuring clarity and compliance to facilitate approvals.
Our CMC development services include preformulation and characterization, comparability and stability studies, and toxicology and clinical formulation, ensuring safety and efficacy throughout the development phases.
At CMCAssist, we pride ourselves on delivering tailored solutions that meet the highest standards of quality and regulatory compliance. Partner with us to transform your scientific breakthroughs into successful, market-ready therapies.
Meet our team of expert CMC consultants
18 years in drug development, 10 years in academia & formerly employed at Novozymes and Novo Nordisk. I’ve worked with a total of 30+ drug development projects and put 5 drugs on the market. Extensive knowledge in the areas of peptides, proteins, mAbs, ADCs, small molecules, cancer, cardio vascular, metabolics, haemophilia, personalized medicines, vaccines & inflamation. Currently involved with CMC & regulatory strategy.
9 years in drug development and 10 years in academia. Formerly employed at Maxygen & Novo Nordisk, where I’ve worked with peptides, proteins, mAbs, haemophilia, metabolics, inflammation, cardiovascular. Furthermore extensive knowledge in areas of biophysics, characterization, formualtion development, CMO & CRO management & CMC writing.
Multiple years of experience with bioinformatics & python programming. I’ve performed various in-silico analyses including protein modelling, characterizations & simulations. Addtionally, I’ve built CMC regulatory templates, aided in regulatory documentation, & been involved with project management & VC funding.
10 years at the Laboratory of The Danish Medicines Agency(DKMA) & 5 years in academia. My experiences at DKMA is in regulatory control of biological medicinal drug products available on the Danish marked regarding quality & documentation. I have knowledge of regulatory guidelines, QA/QC & working according to a quality system.
