Scientific advice is an incredibly helpful tool in clarifying regulatory requirements, answering questions, and gathering information. Pharmexon assists the entire process from pre-advice strategy to attendance at advice meetings. The wide array of experts comprising the Pharmexon team allows the client to feel as prepared as possible when pursuing scientific advice, knowing these expertise can be available throughout the entire journey.
The Pharmexon team can assist with question framing, dossier preparation, and regulatory strategy. Combining the team’s expertise and regulatory understanding, the knowledge offered will enable the client to identify risks early, ensuring the development plan is within compliance of the regulatory bodies. These experts can provide real-time feedback to the client through meeting attendance, offering active participation and a unique, objective perspective. Overall, Pharmexon and its incredibly knowledgeable team enables the greatest value of scientific advice meetings to be achieved, setting a positive tone for the rest of the regulatory journey.
Obtaining an Orphan drug designation enables those with rare diseases and conditions to find medicinal support, and with the designation comes also market exclusivity and other benefits. Pharmexon and its team of experts have experienced applying for ODD’s in the past and continuously use knowledge gained to ensure the client possesses a feasible regulatory strategy, from confirming that the medicinal product meets the criteria for orphan designation and obtaining the correct documentation to helping submit the actual application to the relevant party.
Pharmexon can also provide support at regulatory meetings, using a hands-on approach to create a detailed and regulatorily compliant dossier. Post designation support is also offered, helping the client through the commercialization process and maintaining the ODD designation through the products life cycle.
Pharmexon provides comprehensive support through the entire PIP application process utilizing its extensive list of knowledgeable experts with long histories of successfully dealing with PIP’s. Advice such as the optimal period for paediatric studies and its fit within the overall drug development process is offered, in addition to substantial assistance with the preparation of the PIP, vouching for its validity. Pharmexon can also act as a liaison for between the regulatory agency and the client, advising on the correct questions, studies, and type of data to answer and collect.
PIP waivers and deferrals can also be handled by Pharmexon, with the company’s experts providing extensive experience in justifying these amendments to the regulatory authorities relevant to the PIP.
All incredibly important aspects of pharmaceutical development, Pharmexon uses its vast list of experts and unique logistical abilities to assist in the development of relevant documents, conversations with the necessary regulatory bodies, and project management, streamlining the process and coordinating between different parties to receive high quality and timely results.
Pharmexon’s array of experts not only possess extensive general knowledge of the industry, but specialized expertise in certain aspects such as non-clinical trials or CMC consultancy. As such, the client can be confident that the advice given stems from a reputable source with many years’ experience in that specific field of pharmaceutical development. Whether there is risk to be assessed, studies to be conducted, or regulatory documentation to be created or reviewed, the team at Pharmexon can assist.
Offering a wide range of services related to medical devices, Pharmexon can help through the entire process of medical device applications through to post-application monitoring, while also providing tailored services for a portion of the process. Working with experts in this field, Pharmexon global network of experts provide credible advice on everything from determining the regulatory pathway to quality system implementation (utilizing regulatory frameworks such as ISO 13485, 21 CFR part 820, and MDSAP).
Medical devices can often complement other products, as such Pharmexon can coordinate with experts in each area, easing the logistical problems, smoothing the process no matter the many parties involved. From industry experience to certifiable excellence, Pharmexon provides advice or hands-on support throughout the entire pharmaceutical sector.
Pharmexon offers on-site support for both clinical and nonclinical studies, monitoring these studies using extensive knowledge in the industry to ensure that the studies will be helpful for the next stage in the drugs development or market authorization. Using experiences of past studies and broad knowledge of their processes, Pharmexon can monitor for Good Laboratory Practices (GLP) while also monitoring for the effectiveness of the trials in relation to the goals set by the client.
Through this attention to detail, Pharmexon can provide study specific advice using experts well-versed in the field, advice that is timely and hands-on due to the on-site support offered. The client will have the ability to seek real-time advice and answers to potential risks or issues, saving the client time and money through utilizing their resources efficiently but still achieving the required level of GLP and other regulatory standards.
Utilizing experience not only within the industry but also experience within many regulatory agencies, clients can be assured that Pharmexon can help prepare for GMP inspections including performing internal audits. The team at Pharmexon know exactly what to look for, giving timely advice to the client on changes needing to be made through a Gap Analysis. Inspection simulation, readiness assessments, and documentation management are other examples of how Pharmexon can help the client be confident in their processes when GMP inspections occur and will have a group of experts to turn to if any issues may arise.
Pharmexon offers many services relating to submission management, utilizing a team of project managers and experts that are knowledgeable in different aspects of the submission process. CP, DCP, and National submissions all vary in regulatory requirements and other factors. As such, Pharmexon aids the client using their comprehensive knowledge of these requirements, preparing them to face a changing regulatory landscape. Expert writing and reviewing, in addition to expertise within the eCTD format are other examples of how Pharmexon provides unique assistance to the client, stabilizing the submission process and increasing success rate.
Pharmexon also offers quality control services, reviewing documentation for completeness, accuracy, and consistency, using knowledge founded from experience dealing with regulatory bodies, increasing the likelihood of a smooth submission process. If issues arise, real time advice and answers to questions by the agency can be provided by Pharmexon. Overall, Pharmexon offers services all through the submission process enabling the client to feel prepared, knowledgeable, and confident about their submission.
+420 602 378 935
Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia
