Clinical Adboards

At Novumgen, our team of clinicians, pharmacists, and scientists work closely together to identify unmet patient and healthcare professional needs. Through this collaborative approach, we are able to design products that add value to currently available therapies and address these needs in a meaningful way. One important aspect of our product design process is creating containers and closure systems that reduce the risk of dosing errors. We also prioritize the development of innovative dosage forms that save time and minimize the potential for errors, all with the ultimate goal of improving the patient experience and outcomes. By focusing on these key areas, we strive to continuously improve the effectiveness and accessibility of our products for patients and healthcare professionals alike.

Development strategy

At Novumgen, our team is comprised of a wide range of specialists who are responsible for managing various aspects of our business. This includes analytical and formulation development, manufacturing, patents, business development, project management, regulatory affairs, pharmacology, product and packaging design, supply chain, and procurement. By bringing together this diverse group of experts, we are able to approach product development from multiple angles and ensure that all aspects of our operations are running smoothly. Our team follows a Quality by Design (QbD), Advanced Quality by Design (AQbD), and Design of Experiment (DoE) approach when designing products to fulfil unmet needs of patients and healthcare professionals. This systematic approach allows us to carefully consider all aspects of product development and optimize our processes to produce the most effective and high-quality products. In addition to designing innovative solutions, our team also works to monitor the timely execution of our projects and minimize deviations to ensure that our products are delivered on time and meet all necessary regulatory requirements.

Regulatory affairs

At Novumgen, our team is responsible for managing CMC (Chemistry, manufacturing, and Controls), pharmacology, pharmacovigilance, and compilation based in the USA, UK, and India. We take a highly proactive and detail-oriented approach to ensuring compliance throughout the process, from development to submission. Our team closely monitors and approves progress at every stage to ensure that all of our products meet the highest standards of quality and safety. One of our key goals is to curtail the time of submission and provide all necessary support for gap assessment and dossier submission. We have a dedicated team of experts who work closely with regulatory authorities to ensure that all of our products are thoroughly reviewed and approved in a timely manner. By working together with our partners and stakeholders, we are able to navigate the complex regulatory landscape and bring our innovative products to market as efficiently as possible.

Patent

At Novumgen, our team is responsible for evaluating the scope of live patents and any potential trademark infringements in order to define the development strategy that will maximize the scope of the patent. This is an important part of the product development process, protecting our intellectual property and ensuring that our products are positioned for success in the market. To manage our patent strategy and compilation, we have a dedicated team of experts who are well-versed in intellectual property law and the nuances of the patent process. This team works closely with our scientific and technical staff to ensure that all of our products are thoroughly reviewed and that any potential issues are addressed before they become a problem. By carefully managing our patent strategy, we are able to protect our innovations and bring them to market with confidence.

Project Management

At Novumgen, our team is dedicated to ensuring timely execution and monitoring of all of our projects. We understand the importance of keeping our partners up-to-date on the exact status of on-going projects, and we work hard to provide regular updates and promptly advise of any deviations. We are always available to listen to our partners on any aspect of our projects, and we strive to maintain open and transparent communication throughout the development process.Our team is highly responsive and proactive, and we work hard to ensure that all of our projects are delivered on time and to the highest standards of quality. We understand that our partners rely on us to deliver results, and we take this responsibility very seriously. By working closely with our partners and keeping them informed every step of the way, we are able to build strong and productive relationships that lead to successful outcomes.