Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material. The entire process involves near-constant correspondence between Regulatory affairs departments and the global Health Authorities (HAs).
Given the increasing demand for globally acceptable products, life sciences companies are continuously trying to expand their footprint to global markets. But with myriad and diverse regulations and submission formats to be followed, and numerous data points to keep track of, the submission process for global market entry and product registration may become complex for manufacturers. Thus, even health authorities are working towards harmonizing the global Regulatory requirements to ensure streamlined and easy-to-review submissions. Keeping that aside, it is a priority for a manufacturer to choose a reliable solution that suits their global submission requirements. In such cases, what exactly a manufacturer must consider while choosing an appropriate solution? What kind of factors they should ponder upon? Let’s take a look.
- Flexibility: Companies must understand and see how flexible a solution is, not only in terms of easy and smooth submission process but in terms of the deployment methods. Given the utmost data security requirements in the conservative field of life sciences, they must think twice in choosing an external software. They should clearly validate the flexible deployment methods like cloud-based and on-premise models that suit their eCTD publishing and submission requirements.
- In-depth Knowledge and expertise: Sometimes, software alone won’t fit the submission requirement, the personnel that assist the software integration is also important. If the company is opting for external software, they must also validate the vendor’s expertise and knowledge on the required submission process. Because that knowledge might have actually been put to use while designing the base platform of software. It is the software vendor’s in-depth knowledge and expertise that drives the submission process successfully even in the times of complexities. In addition, it is wise to validate the software in terms of its cutting-edge technology like machine learning, which makes for compliant eCTD publishing and submissions.
- Global reach: As with evolving regulations, each region has its defined set of submission processes and requirements – most of them are already accepting the electronic Common Technical Document (eCTD) format. In such cases, the software that companies are adopting must be equipped to be suitable for all regional formats, which can enable a hassle-free transition while aiming for time-bound global reach. The software should be compliant supporting 21 CFR Part 11 standards for various health authorities. In addition, it should be equipped with features like cloning, cross-reference, the capability to integrate with the leading rDMS and PDF manager.
- Interoperability – The submission tool or software must easily be integrated with other tools such as content management solutions and other authoring tools that help in smooth submissions. It should facilitate seamless integration with leading Regulatory Document Management Systems (rDMS), the client is already using, in a secured manner. So that the applicants can assuredly call their confidential data into the new platform without any need to create any extra folders.
To conclude, as several HAs making eCTD submissions mandatory, there persist global differences in Regulatory submission requirements. We do agree that there is a dire need that health authorities should quickly harmonize the global Regulatory requirements to ensure the streamlined and easy-to-review submissions. Meanwhile, companies must have explicit knowledge about the software they are about to integrate and its intended impact on their submission processes. Companies must act wise and deploy all the possible ways to validate a software solution. Evaluate Freyr SUBMIT PRO with that of your submission requirements. Request a demo.