Developing medicines takes time, money and expertise as well as thorough understanding of the regulatory field. Regulatory CMC experts – that is, pharmaceutical chemical experts – possess in-depth knowledge of regulatory guidelines. By involving CMC experts early on in your development process, you can be confident that your drug development complies with these guidelines, minimising the risk of regulatory delays later on. Engaging CMC experts early in your non-clinical and clinical development can also streamline your drug development timeline, especially when it comes to data between phases. For instance, if the composition of your drug product has to be adjusted between the non-clinical and clinical phases, our CMC experts can guide how to validate the data from pre-formulation for its relevance to the final formulation. We provide guidance on the most efficient approaches for manufacturing, quality control and analytical methods, enabling you to address potential roadblocks well in advance. This proactive approach saves not only time but also your valuable resources.
CMC responsibilities in writing marketing authorisation applications
CMC experts are responsible for writing the documents that demonstrate the pharmaceutical quality of both the active pharmaceutical ingredient (API) and the drug product in the marketing authorisation application (MAA). These documents describe the following elements of the process:
- raw materials
- manufacturing process and its controls
- intermediates
- specifications
- analytical methods
- packaging materials
- tests supporting shelf life and storage conditions.
CMC experts follow the EMA (European Medicines Agency) and ICH guidelines when writing the required documentation. The documentation data comes from a variety of sources, such as R&D reports and raw material suppliers. It can include, for example, copies of manufacturing batch records, product development reports, raw material suppliers’ statements and analysis certificates, analytical method validation reports and stability study result tables.
Our expertise ensures that your dossier will meet the current regulatory requirements, with a sufficient level of detail, naturally aiming for a positive outcome as well as easy maintenance of the marketing authorisation in the future.
Valuable strategic advice from regulatory CMC experts during drug development saves time and money – and improves quality
CMC experts have valuable insight into the recommended guidelines already at their draft stage as well as into the way regulatory authorities typically interpret these guidelines. This is useful in determining the most appropriate studies for developing the formulation, manufacturing method or the quality control methods. Furthermore, this strategic approach ensures that the required results are available at the time of submission of the marketing authorisation application (MAA).
If you are developing a generic product, we will help you choose the best reference product, while taking into account your planned market area. Through careful early-phase planning and active involvement of CMC experts, it is ensured that the necessary product characterisation data of the reference drug product is available, which is a crucial component for regulatory filing. As regards your drug substance, we can help you to assess the supplier with the most beneficial regulatory profile for your drug product registration. In addition to assessing your active substance, we evaluate the regulatory compliance of all your materials, including excipients and packaging materials. We also conduct a pre-evaluation for nitrosamine risk assessment and elemental impurity risk assessment and assess the potential impact of impurities on the quality and safety of your product.
We can advise you on implementing appropriate control strategies, reducing the likelihood of issues arising during later stages or post-approval. Wherever you intend to market your product, we can make sure that your drug product, drug substance specifications and your manufacturing process development are compliant with the applicable regulatory requirements. Our CMC experts have expertise in developing robust manufacturing processes for pharmaceuticals, and we can make sure there is a correlation between QTPP (Quality Target Product Profile), CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters) identified in the development phase and in controlling the commercial scale manufacturing. In other words, our CMC experts will ensure the regulatory compliance of your manufacturing process as well as batch-to-batch consistency.
During the development and regulatory phases, we can evaluate your stability monitoring plans and provide valuable recommendations. For example, sometimes it is worth analysing more than the minimum requirements – the results can then be used as an argument for why a specific feature does not have to be routinely tracked in commercial batches. Our CMC work makes sure you have sufficient stability data at the MAA stage and that the performed stress tests are adequate to justify the information in your product information texts.
Here’s a summary of the six main benefits of involving regulatory CMC experts in early drug development
In summary, involving regulatory CMC experts in early drug development offers numerous valuable benefits for your drug development process, including:
- ensuring regulatory compliance
- accelerating the development timeline
- optimising manufacturing processes
- mitigating risks
- developing a robust regulatory strategy
- optimising costs.
Our CMC expertise can significantly contribute to the successful development and approval of your pharmaceutical product – from early drug development to market and beyond.
CMC expert services at Medfiles
Medfiles’ CMC experts have extensive work experience in pharmaceutical manufacturing, analytical chemistry and working with regulatory agencies. We have assisted our clients with several development projects and technology transfers. When you need first-class CMC expertise in your manufacturing processes and analytics, coordination of technology transfers, writing validation plans and reports, risk assessments for nitrosamines and elemental impurities and writing clinical trial application documentation (IMPD, IND), you can outsource these tasks to our competent and experienced CMC team.
You can trust us with your documentation work for your marketing authorisation applications: documentation for module 3 or Part II, quality overall summaries, documentation of the active substance (ASMF, DMF and CEP) and requests for additional information during marketing authorisation procedure.
Our experts are more than happy to help you with your drug development projects.
