Frequently Asked Questions (FAQ)
What support can BLA provide regarding clinical study reports?
BLA has extensive medical/scientific writing experience and established processes, for drafting, managing review, comments resolution, and approval, publishing, and submission of clinical study protocols, amendments, and final study reports.
We have an outline for a clinical study protocol and want to confirm it will be accepted by FDA. Can BLA help us with this?
Yes, our clinical and regulatory consultants can review your protocol outline and provide relevant input to ensure it meets FDA requirements. You can also avail of our scientific writing and e-submission services to help you draft, publish, and submit the clinical protocol to FDA.
What is the nature of your company? How experienced is your team?
We are a company of highly experienced & a balanced combination of FDA-experienced experts, industry regulatory leaders, and professionals with local and global regulation expertise. You can learn more about our team members here.
Do you have any success stories similar to our products or do you have any direct R&D experience in this indication?
Feel free to check out our client testimonials to learn about our success stories in the following therapeutic areas:
- small molecule
- gene and cell therapy
In addition, our consultants have handled products crossing therapeutic areas such as oncology, respiratory, autoimmune, inflammatory, metabolic, and cardiovascular diseases. Our FDA veterans can also provide strategic expertise for therapeutic proteins, gene and cellular therapies including monoclonal antibodies, biosimilars or innovative antibodies, Fc-fusions, enzyme replacement therapy products, cytokines, hormones, CAR-T, and gene therapy.
Do you have any solutions for communication between different language speakers?
Yes, our team members can speak English, Chinese, and Japanese to facilitate communication between different language speakers.
Does BLA provide a complete suite of services for the US IND application?
For US INDs, BLA provides end-to-end solution. Our complete suite of services includes gap-analysis, strategy development, leading consultations with FDA on product development, medical and scientific writing, protocol development, as well as eCTD-compliant dossier compilation, publishing, and submission.
Besides the US, which countries does BLA provide IND/CTA services? (EMA, China, Australia. For Japan and South American countries, BLA works through collaborators)
Our services have global coverage that includes the European Union, China, and Australia. Our collaboration network extends our reach to Japan and South America, as well.
How does BLA assist sponsors craft Clinical Development Plan (CDP) and clinical trial protocol (CSP)? (mention our experts in the clinical and biostat areas. This question is similar to 1&2 below but different)
BLA’s team consists of highly experienced FDA and industry-based clinical pharmacology, clinical strategy, and biostatistics experts who have extensive knowledge on the trial design of Phase I to IV, drug-drug interaction, food-effet and BA/BE studies, and is capable of providing clinical trial-related deliverables, including the CDP and the CSP. BLA can engage with you at any phase and will help you chart up a cost-efficient and results-oriented clinical plan for regulatory success.
Can you author the IND Dossier for a sponsor?
Yes. BLA has extensive experience in dossier preparation, medical and scientific writing of IND documents of all modules, translations, IND Dossier compilation, and submission as per the eCTD requirements. We also provide project management services from the IND initiation to the approval phase, and the maintenance phase as well.
My company does not have certain domain experts (such as a toxicologist or a CMC expert) for the pre-IND meeting with the FDA. Could BLA’s relevant experts participate in the meeting on behalf of my company?
Yes. BLA will be able to participate in any of the meetings with the FDA based on the need of your product and the required area of expertise.
My company already has contracted certain aspects of the IND application to another consultant. Would BLA work with this consultant on the rest of the application?
Yes, we can. Through collaboration and trusted consultation, BLA Regulatory will function as an extension of your team, creating a tailored end-to-end approach depending on your product and your company’s individual needs.
How do I know BLA has the expertise I need? (mention that BLA will have a meeting with the sponsor to introduce relevant expertise)
Please feel free to contact us and we will be happy to schedule a meeting to explain what we do best and discuss if we can provide what your company needs.
Does BLA have any experience with marketing authorization applications (BLAs/NDAs)?
BLA’s team members have hands-on experiences with entire marketing applications in the US, EU, and other countries, including leading pre-marketing application meetings with regulatory authorities, crafting regulatory strategy and execution plan, managing project and resources, compiling, publishing, submission of MA dossier, and managing post-submission regulatory defense through approval.