We help you address each challenge by offering total quality assurance throughout your entire supply chain. Our in-house quality management team, in coordination with our network of collaborators, can provide integrated solutions tailored to the exact needs of your project and depending on its market application. Our solutions may vary from performance of analysis, evaluation of test results, preparation and evaluation of Technical Documents to evaluation of suppliers and sub-contractors.
We have a holistic approach and perform all stages of synthesis, analysis, setting of specifications and monitoring of results in compliance with ICH guidelines, while providing full traceability during the process development, analysis and stability studies. In addition, we evaluate all sources of raw materials (Key Starting Materials and intermediates) in regards to the quality status of the manufacturing site and documentation (Technical Documents, specifications, Certificates of Analysis, Batch Records, etc). Once the development is concluded, we issue a Technical Document for every project, upon request, which includes detailed information about the process specifications, analytical methods, impurity profile and more.
Our IP solutions are designed to mitigate unnecessary business risks and place your product in a protective environment. Our experts have excellent knowledge of the individual patent systems, with a strong focus on the European Patent one, and more than 10 years of experience in patent filing and prosecution. Furthermore, they have a PhD-level academic background in organic chemistry and solid experience in process development for the chemical and pharmaceutical industries.
Here is what we can do for you:
Our competitiveness stems from our innovative R&D approach that is instrumental to our core competencies. We value our knowledge and over the years have built a strong patent portfolio. We use intellectual property strategically, which gives us greater corporate flexibility and increased market value of our products.
Furthermore, we respect other companies’ intellectual property rights (IPRs) and we ensure that our developments do not infringe on existing patents. We invest in trust, transparency and confidentiality with customers, collaborators and partners, to maximise complementarity and promote mutual benefit.
We help you stay informed about the latest regulatory developments in all relevant markets, ensure compliance of your product with industry standards, reduce cost overruns and speed up the time to commercialisation.
We can provide strategic regulatory insight and internal support, from the early stages of development up to final approval and product lifecycle management. This proactive approach helps us to anticipate and overcome any regulatory bottlenecks and ensure a smooth process and product development for our customers.
Our objective is to achieve fast and safe approval of the Drug Master File (DMF) of your product. Our dedicated team has in-depth knowledge of the requirements in highly regulated markets (EU, US, Japan) and extensive experience in submission of DMF, Certificates of Suitability and other Technical Documents in Common Technical Format (CTD), with a track record of over 20 APIs. We can also prepare eCTD of DMFs using regulatory approved software and submit the relevant documents on-line. Most importantly though, we take care of the complete Life Time Cycle (LTC), from the collection of technical information and revision through to evaluation, compilation, delivery, submission, registration and final approval of the DMF.
Our expertise is not limited to administration. We will provide you with the necessary scientific advice to respond to any issue or question raised during the assessment period. Adherence to procedure timetables, constant follow-up and punctual submission of responses is our priority. Furthermore, we will actively monitor the commercial production and advise you on any process modifications that may have an impact on the regulatory compliance of your approved product or can possibly disrupt your supply chain. If changes are needed, we will recommend an appropriate classification or grouping of variations, advise you on the submission of the strategic variation and propose an optimal post-approval cost-and time-plan.