CMC development
During the development of medicinal products one has to keep in mind a number of potential issues in order to be successful in medicinal product authorisation. The sooner the company is aware of the regulatory requirements and plan the research accordingly, the greater the chances of achieving the goal on time mitigating the risk of any delays resulting from the Agency’s further comments and reviews. The inability to comply with regulatory requirements, in the worst-case scenario may result in a failure of getting Marketing Authorization. Needless to say that a well-planned process of product development and research is savings for the company.
At SciencePharma we have widely experienced CMC experts who will be happy to advise you on all aspects of CMC development:
- Nitrosamines risk analysis – to date we performed dozens of nitrosamines risk analyses which were accepted by EU Agencies
- Impurities and genotoxicity issues: we can support you in setting the proper limits for organic and inorganic impurities as well as residual solvents. We offer preparation of justification of impurities limits. Our Team will also help you to assess its genotoxicity potential
- Stability study design covering matrixing and bracketing – it is very often possible to avoid part of the stability study time-points or strengths, which generates savings for the company. Nevertheless, the unjustified limitation of stability study time-points/strengths will result in comments from the Agency, which may even lead to the rejection of the proposed design. Therefore we can propose an optimal design taking into account both: cost-effectiveness and the Agency’s requirements. We will also be able to advise whether or not to perform in-use studies
- Pharmaceutical development – we can support you in designing development studies for your medicinal product. Not sure what tests are required for your product? Photostability studies, extractable and leachable studies, uniformity studies for divided tablets, or appropriate design of dissolution studies for bioequivalence study or biowaivers? Planning research for a chemical, biological or biotechnological product? Our experts are here to support you
- Quality dossier preparation – Our experts have prepared hundreds of 3 Modules and QOS reports. We are familiar with all the current EU requirements concerning the quality aspects of the dossier, thanks to which the content of the documents we prepare is optimized and does not contain any redundant and unnecessary information. This approach ensures the reduction of post-registration variations in the future which generates savings for the customer. We also offer preparation of quality dossier in formats required by non-EU Agencies.
The scope of our support is tailored to the individual needs of our Client.
Write to us and we will choose the most suitable solution for you!