Streamline Your Path to Regulatory Licensure

Navigating the complex landscape of Biologics License Applications (BLAs) can be challenging. BDO offers comprehensive experience in biologics chemistry, manufacturing, and controls (CMC) to guide you through every step of the process, providing a seamless journey from pre-clinical development to commercial manufacturing.

Regulatory Strategy

  • Gap Analysis and Risk Assessment: BDO brings extensive industry experience to identify and address potential hurdles to achieve regulatory approval, ensuring a smoother path to market and reducing the risk of costly delays.
  • Accelerated Approval Evaluation: With BDO's deep understanding of regulatory pathways, clients can assess the potential for an expedited path to approval and select the appropriate submission types, maximizing efficiency and market entry speed.
  • Global Strategy Development: Our global presence and experience allow for the crafting of a cohesive strategy across North America, Europe, and Asia, tailored to your clinical trial status, locations, and anticipated results, ensuring alignment with international regulatory requirements.
  • Project Management: We provide robust project management, tracking, and change control throughout the engagement, helping projects stay on schedule and within budget, while adapting to any changes in regulatory landscapes.



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Document Preparation and Submission

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Data Sourcing and Compilation
BDO leverages its extensive network and skills to gather and compile all necessary data and inputs for submission, ensuring completeness and accuracy, which is critical for regulatory success.

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Filing Preparation and Review
With BDO's skilled preparation, writing, and review of filings for IND, BLA, and post-approval documents, clients benefit from high-quality submissions that meet regulatory standards, reducing the likelihood of rejections or requests for additional information.

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Document Management
BDO provides support to secure document storage and manages Module 3 of any eCTD regulatory filing, providing clients with peace of mind that their sensitive information is protected and organized for efficient retrieval and submission.

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And other services, including authoring, functional and cross-functional reviews, and data verification, to complete your BLA filing in a timely manner.

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