Looking For Support With Your Biologics License Application (BLA)?

Overcome the unique challenges of BLA submissions with our experienced team of regulatory experts.

Common Challenges in Preparing a BLA

Are you facing any of these uncertainties?

Understanding FDA Regulations and Requirements

FDA has a vast array of regulations and guidance documents governing the content and format of a BLA.

  • How do you determine which ones are relevant to your application?
  • How should these regulations be interpreted for your specific biologic product?
  • The CMC section is particularly tricky. How do I know if I’m providing exactly what is needed?

Our experts help you navigate these complexities, ensuring compliance with all applicable guidelines.

Ensuring a Complete and Well-Written Submission

A BLA requires thousands of documents and extensive data.

  • What documents are necessary for submission?
  • How do you meet FDA’s stringent formatting and submission requirements?
  • How do you ensure your content is framed appropriately for FDA reviewers to minimize information requests?

Work with Facet to ensure that your submission is compelling and tells the right story about your data.

Addressing Content Concerns

Every BLA is unique, depending on the product type and clinical data available.

  • Do you have all the required components for FDA acceptance?
  • Are your documents structured and written in a way that FDA reviewers will clearly understand?
  • What strategies help maximize the likelihood of first round approval?

We help streamline content development, ensuring clarity and regulatory alignment.

Partnering with our experienced team can significantly increase your chances of success. This includes streamlining your submission process, getting the most out of your pre-BLA meeting, and increasing the likelihood of approval.

 

Ready to navigate the complexities of the BLA submission process with confidence?

Facet’s team can help you expertly navigate the BLA process by providing clear guidance every step along the way. 

Communicating with FDA

Pre-BLA Meetings

A pre-BLA meeting significantly increases the chances of approval.

  • Is a pre-BLA meeting necessary for your product?
  • How long does it take to get a meeting with FDA?
  • How much does a pre-BLA meeting cost?
  • When should you schedule it, and who should be involved?
  • What key questions should you be prepared to ask or answer?

We will guide you through the process, helping you determine the right timing, participants, and discussion points.

Corresponding with FDA

Talking to FDA during the preparation of the BLA may be necessary when unexpected issues arise..

  • What’s the best way to engage with FDA if you haven’t had a pre-BLA meeting?
  • Do you need a US Agent?

Facet can answer many of the questions, and act as your US agent. Our team can facilitate direct FDA communication, represent your company, and ensure the right tone to get the answers you need.

 

 

Managing Submission Timelines

Key Timelines to Consider

Understanding submission timelines helps ensure a smooth process.

  • How long does it take to prepare a BLA?
  • Are there any ways to save time when preparing a BLA?
  • What are the expected FDA response times after submission?
  • How can you minimize delays in the review process?

Our regulatory experience helps streamline BLA preparation and expedite submission.

Personnel Considerations

Most small organizations rely on a single regulatory expert for early development, but a BLA requires a broader, integrated team.

  • Should you hire internal staff or work with external consultants?
  • Do you have the right expertise in regulatory affairs, toxicology, CMC (chemistry, manufacturing, and controls), and clinical/statistical analysis?

We provide an integrated team of experts under one roof to support your BLA preparation.

Financial Considerations

Budgeting for Your BLA

A BLA requires significant financial planning.

  • What are the expected costs for BLA preparation?
  • How much does FDA charge for review fees?
  • Are there cost-saving strategies for the submission process?

We help you budget effectively and minimize unnecessary expenses through efficient planning.

hexagon_1-1

At Facet, We’ve Overseen 250+ Products Get To and Through FDA

Our team has the experience & knowledge to talk the talk AND walk the walk. If you have questions, our team has answers.

hexagon_2

Facet Averages a Minimum of 25 FDA Formal Meetings Each Year

Our team supports formal AND informal meetings with all FDA centers: CBER, CDER, CDRH, and OGD.

Why Choose Facet for Your BLA?

noun-time-7459200-223669

Reduce Time-to-Market:

Our proactive approach anticipates issues early, accelerating preparation and submission while controlling costs.

noun-star-7472172-223669

Increase Approval Success Rate: 

We leverage deep expertise in FDA regulations and a strong track record of successful BLA approvals.

noun-risk-6908906-223669

Mitigate Regulatory Risks: 

We have never received a Refuse to File (RTF) decision. Our rigorous planning, document preparation, and regulatory strategies ensure high-quality submissions.

noun-brain-3369460-223669

Gain Access to Regulatory Experts:

Our experienced team provides comprehensive knowledge of BLA requirements, guiding you at every step.

noun-settings-1911807-223669

Optimize Internal Resources: 

By working with our seasoned team on your BLA preparation, you streamline internal operations and free up valuable resources.

Your Trusted BLA Partner
 
Unlike other consulting firms that focus on only one aspect of the BLA process, we provide end-to-end support to maximize your success.
noun-check-7539335-223669
Facet’s Approach
 
Combines deep FDA experience, holistic support, and alignment with your company’s business goals to optimize regulatory outcomes.
noun-x-7350039-C73750-1
Other Consultants
 
Lack hands-on FDA submission experience and do not integrate regulatory strategy with business objectives.

Ready to Discuss Your BLA Strategy?

Let’s Talk and Ensure Your Submission is Set Up for Success.

Frequently Asked Questions

What services does Facet Life Sciences provide for FDA meetings?

Facet offers comprehensive life sciences consulting support, including strategic planning, meeting preparation, scientific expertise, and team coaching to support your BLA. We help you navigate the entire regulatory process to position you for successful outcomes.

What can I expect during the BLA preparation process?

Our team works closely with yours to develop a tailored strategy, create and address precise questions, prepare background materials, and ensure that all attendees are well-prepared for a successful interaction with the FDA. These preparation meetings are a two-way collaborative effort between the Facet team and your organization.

What should I do if I feel nervous about my upcoming FDA interaction?

It’s normal to feel nervous or uncertain! If you don’t have a plan for your FDA meetings, reach out to the Face team for a consultation. Our experts will review your journey and provide the support you need to feel confident and prepared for your FDA interactions.