At CMCAssist, we specialize in CMC consultancy, offering expert guidance on regulatory documentation, formulation development, and comparability assessments.
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
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. In addition, we can aid in CMO/CRO selection and management, aswell as perform important in silico analyses to aid in formulation development or lead selection.
Focus areas:
• Formulation, pre-formulation, characterization and comparability
• Release specifications, in-use and shelf-life stability
• Peptides, proteins and novel drug concepts
• In silico degradation product and lead selection analyses
• Quality strategy and documentation: IND, IMPD and quality overall
• IMPD formatting
• CRO and CMO selection and project management
• Troubleshooting, root cause and risk assessment
• Due diligence
Please reach out on LinkedIn or leave a mail at info@cmcassist.dk, so we can discuss your personal needs.
Company Details
- Employees
- 4
- Founded
- -
- Address
- Nordre Fasanvej 215, Frederiksberg,capital Region Of Denmark 2000,denmark
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://cmcassist.dk/
- Keywords
- CMC, Quality documentation, Formulation development, Drug development, Biologics, Regulatory quality documentation, Protein drug, peptide drug, personalized medicin.
- HQ
- Frederiksberg, Capital Region of Denmark
Cmcassist Aps Questions
Cmcassist Aps's website is https://cmcassist.dk/
Cmcassist Aps's LinkedIn profile is https://dk.linkedin.com/company/cmcassist
Cmcassist Aps has
4 employees.
View email and phone details for 4
employees at Cmcassist Aps.
Cmcassist Aps's industry is
Pharmaceutical Manufacturing
Cmcassist Aps's categories are Pharmaceutical Manufacturing
Cmcassist Aps's founding year is 2016
