Biopharmaceutical development is an extensive and complex process. Managing processes like Investigational New Drug (IND) applications or the manufacturing, quality, and regulatory side of the processes—collectively known as CMC, or the Chemistry, Manufacturing and Controls—requires a highly skilled team with multiple areas of expertise. For many companies, developing such a team in house can be challenging. Even if they wanted to, finding professionals with the right skill sets to manage each CMC stage can be difficult. Even companies that already have internal experts sometimes have multiple initiatives underway and need extra help.
Choosing the right biopharma partner can bring significant value, including faster, more successful IND applications.
How biopharma partners can help
The biopharma regulatory landscape is continuously evolving. Just staying on top of the changes can present an ongoing challenge to drug developers, especially in the areas of new small molecules, biologics, cell and gene therapies, and medical devices. This is where the right biopharma partner can add significant value—by helping companies design, plan, and execute strategies from conception to go-to-market and everything in between. They can be especially beneficial with IND processes and helping companies avoid clinical holds.
The value of biopharma partnerships includes the following:
- Global regulatory strategy development
- Product development regulatory guidance and support
- IND submission and maintenance, including formatting, compiling, and publishing
- Interacting with regulatory agencies
- Managing all aspects of regulatory affairs and pre-IND meetings
For smaller organizations, a biopharma partner can serve as a virtual regulatory department, providing expertise without having to hire expensive full-time experts.
Choosing the appropriate partner
When looking for a biopharma partner to help with an IND application or other regulatory strategies, it is essential that companies choose one whose capabilities best complement their company’s existing team. The best partners are those who work alongside internal staff, acting as a single, cohesive team with a shared vision of success. They should embrace the company’s mission and understand that an optimal partnership brings mutual success and helps deliver potentially life-saving treatments to individuals in need.
Other capabilities to look for include extensive experience with exploratory and creation stages of drug development. The best partners can leverage their expertise and collective knowledge to suggest ways to develop the product’s path even further while still staying within the project’s scope.
Another capability that drug developers should look for is the ability to ensure that every electronic submission they manage is of the highest quality and adheres to all local regulatory requirements, including 21 CFR Part 11 compliance in the U.S. Using validated and 21 CFR Part 11 compliant publishing software that is widely recognized within the industry and across Regulatory Agencies (including the FDA) enables a partner to publish and electronically submit an IND or NDA/BLA and subsequently manage the lifecycle for either of these types of applications.
Additional capabilities to look for include the following:
- Formatting and pre-publication services to ensure documents are submission-ready with the necessary bookmarks and hyperlinks for inclusion in an eCTD submission
- Report-level publishing of documents (e.g., clinical study reports) for inclusion in regulatory submissions
- Submission of Drug Master Files (DMFs)
- CTA submission support outside the U.S.
Partnering for the journey forward
The goal of bringing an innovative drug to market is to help people live healthier lives. This passion is what drives drug development companies in all that they do. The right partners will have that same passion. Syner-G is an excellent choice.
Whether a small company requiring management of all electronic regulatory submission needs or a large company requiring assistance with a single submission, Syner-G will tailor its offerings to their client’s specific needs. Once the decision to partner with Syner-G is made, its Regulatory Submissions staff becomes a valued member of their client’s team, delivering value every step along the way.