CMC & Medical Writing.
Smart dossier planning for production and beyond.
New product submissions, extensions or changes in manufacturing (manufacturing or analytical transfer changes in quality parameters, etc.) require the creation or up-date of the chemical manufacturing and control (CMC) module (M3) of your dossier.
Our consultants can offer all the advice and support you need to create or change all the relevant CMC documents to support submissions.
Our team have extensive experience working directly in manufacturing plants and understand exactly what is required in your dossier regarding quality, manufacturing, and supply processes.
Combining regulatory intelligence with GMP guidelines creates compliant and smart documentation that is designed to meet authority requirements and reduce the level of impact from future changes.
We do this by:
- Translating legislation into clear requirements specific to the type of product.
- Apply our latest knowledge to continuously improve dossier content.
- Create smart content to avoid additional requests from authorities and to minimize changes with possible regulatory impact throughout the lifecycle of your product.
- Ensure that all dossier sections contain compliant information which adequately supports your application.
Regardless of whether your dossier needs to be created from raw data (raw materials specifications and monographs, process validation or batch records, finished product specifications and stability data), or your dossier already exists and just requires up-dates, you can be sure our regulatory team has the expertise and experience to find the right solutions for success.
Ensuring experienced input to your dossier.
Effective medical and technical writing requires expertise in many areas including scientists, pharmacists, and medical doctors.
As all parts of your dossier are equal in importance this essential knowledge and medical practice experience comes together in our expert advice and creation of the clinical and nonclinical modules of your dossier (M2.4, M2.5, M2.6, M2.7, M4, and M5), and Environmental risk assessments (M1.6.1 and 1.6.2).
Our team can prepare these modules for full or abridged dossiers depending on the type of application and product nature, including biologic products that are non-GMO or GMO based.
We can also provide this expert support with the creation of product information based on product indications and provide extensive consultation regarding the preparation of promotional materials.
CMC writing: Six tips for delivering top-class dossiers.
Practical pointers to navigating authority guidance and getting the balance of technical eCTD content right first time.
From the conception of a pharmaceutical product, data is captured about its chemistry, about its manufacturing and about any relevant controls.
When it comes to applying for marketing authorization, much of this information will form the basis for the CMC sections of the eCTD dossier (Module 3: how a product was made and tested) for submission to various licensing authorities.