Is Your CDMO Listening to the Needs of Your Small Company?

 

Small companies can regularly encounter situations whereby contract organizations devote their best people to more significant sponsors. Thus, to make sure you get the attention your small business project deserves, you must take some proactive steps.

For example, you will need to reflect on and refine your style of management. A small business that communicates well with a CDMO and is also very organized will do well even when in competition with larger organizations that may have FTEs with a contractor. This is because regardless of the size, the project is yours, and basically, you are delegating responsibility to the CDMO or CRO.

Continue reading this blog to learn meaningful kick-off meetings.

Sovereign Pharmaceuticals is the best CDMO Pharmaceutical Company in America. We are dedicated to exceeding regulatory and quality and requirements, as well as focusing on our customers. We achieve this through empowered, dedicated, and motivated employees.

Guidelines for Meaningful Kick-off Meetings

Here are guidelines for meaningful kick-off meetings:

1. Share Your Personal Background

This is your best opportunity to provide helpful background and create expectations for your new team. It also allows you to introduce yourself, expectations, background, and your role at your company. While this is personal, it must also be detailed with information that provides the basis for the work requested of the CDMO or CRO.

You should share information like how you got involved in the project, the things you find interesting, and your expectations for success. It is best to let them know what you are expecting right from the start.

To understand how they are thinking and the amount of support from you that they expect, ask the team what they need from you to make it a success.

2. Create a Vision and Priorities

You want to share with your new team the location of the project, as well as how their activities tally with your development program. You also want to review the statement and contract of work and the process for completing any change orders.

This is the perfect time to get their feedback on other studies that you think may have added value to your program. You want to keep an open mind to these ideas because you don’t need to agree to add value to your program instantly. In the end, you may find that these will become valuable budget considerations as the program develops.

3. Establish the Project Team

An essential part of the meeting would be to share an organization chart that includes your business’s team. You must include key members from your communication via teleconference or have them with you.

You want to work closely with the CDMO’s project manager and create a communication plan to establish responsibilities and roles for workers from each organization, how to raise topics that need management resolution, and how they can communicate with each other.

4. Make Provisions for Future Meetings

The first of many interactions should be the site initiation visit. Establish the logistics for information transfer and logistics. Most CDMO, such as a solid dose CDMO, will have a cloud-based means of organizing project files, and your company may also have one.

You want to consider how this project aligns with your company's requirements for planned regulatory submissions.

How to Pick a CDMO Pharmaceutical Company

 

Perhaps you have a breakthrough molecule that you wish to develop. Investors are all over you, and you must see this drug through to commercialization as quickly and efficiently. Your first action might be to get a manufacturing team, establish the infrastructure and make this project a priority at the expense of all other development initiatives.

We recommend that you stay calm and try not to be in a hurry. It is crucial for you to consider working with a CDMO such as a solid dose CDMO. This is because they are more likely to help you reach your goals more economically and efficiently. Continue to read this article to learn how to select the best CDMO.

Sovereign Pharmaceuticals is the number one CDMO Pharmaceutical Company in America. We are committed to exceeding quality and regulatory requirements, as well as focusing on our customers. We do this via dedicated, empowered, and motivated employees.

Guide to Picking a CDMO

Here are things to look out for when choosing a CDMO:

1. Capabilities and Technology

You want to choose a pharma product development partner that possesses the ability to support you both now and in the future. Contract Development and Manufacturing Organizations with equipment built for quick turnover will have higher production capacity and flexibility. Choose a CDMO with the ability to maintain your quality testing desires and has a competent tech transfer process.

Be on the lookout for pharmaceutical manufacturing partners that use new equipment and approaches. Single-use technology has several advantages. A few of such merits include the elimination of cleaning deficiency risk and the reduction of turnaround times.

Contract Development and Manufacturing Organizations working with single-use will have improved suppleness of their ability as a result. Newer equipment helps prevent costly loss of your product, providing high-yield filling.

Computerization strategy is an essential technology factor to estimate by—computerization within an isolator system guards against the primary source of contamination, which is humans. To be compliant, some regulatory standards now necessitate this setup.

2. Partnership

You want to choose a true partner, not just a source. A flexible partner may co-invest purposefully to develop the required support capabilities and work with you to find production capacity. Working closely with your partner will enable proper communication and readiness for new regulatory encounters.

3. Regulatory Compliance

This is one ultimate factor in choosing a CDMO partner. The pharmaceutical regulatory environment constantly evolves, and your pharmaceutical contract manufacturing partner must keep up. It is avoidable to be out of compliance and can be a costly blunder for your business.

A solid pharmaceutical manufacturing partner will be abreast of future policy changes and help you stay compliant. You want to search for a CDMO that treats quality systems and regulations as a priority.

We believe you are interested in choosing the right Contract Development and Manufacturing Organization partner because everyone wants the best. Contact us at Sovereign Pharmaceuticals to learn how we can assist your manufacturing needs. We are a CDMO pharmaceutical company with a difference, staying focused on our customers and continuously upgrading our facilities and equipment to meet their demands. Contact us today.