We have long-standing regulatory knowledge and provide a comprehensive range of CMC writing services to streamline your application while taking a phase-appropriate approach.
Integrated. Proven. The smartest path to your clinical milestones.
The assessment of a drug application by regulatory agencies is a complex process that involves multiple stakeholders. For some companies, Chemistry, Manufacturing and Control (CMC) writing and dossier compilation can be a resource-intensive and costly process that can delay or even derail the drug development process.
Our regulatory CMC team has expertise in all areas of product development from small molecules to oligonucleotides over nanomedicines to biologics such as vaccines, monoclonal antibodies, and peptides. We also have a deep understanding of the regulations for drug substances, pharmaceutical excipients, packaging materials and drug-device combination products.
Our approach means you stay ahead of the game when it comes to advancing products to the clinic, accelerating the journey and enabling greater adaptability and flexibility in your project.
From early development through manufacturing, we provide regulatory advice and compile your application by using phase-appropriate standards.
We are experts in writing scientific and technical reports using a dossier-centric approach. This means we keep the final application in mind throughout to ensure consistency, completeness and readability.
We understand that a consistent and compliant regulatory dossier is the key to obtaining timely clinical trial approval and smooth marketing authorization. However, the path to approval may be burdensome. That’s where our CMC regulatory services team comes in, helping you to accelerate the drug approval process.
For more than 25 years we have focused on (CMC) and can offer you in-depth knowledge, insight and unparalleled experience.
We have comprehensive experience complying with regulations in all major regulated markets, including the US and Europe.
Maintaining compliance with new legislation and guidelines can be a resource-intensive challenge for pharmaceutical companies and is a key area where we can help. Our team supports you by assessing and interpreting regulatory documents on your behalf. Based on case-by-case assessments of the procedures or principles already in place at your facilities, we assist you with the implementation of new legislation to ensure you achieve compliance.
Our experts share their deep, scientific understanding and insights into the regulatory environment and CMC writing.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.