Biologics

Biologics

The Biologic product development framework is replete with regulatory complexity and nuance as well as substantial scientific and manufacturing challenges unseen in traditional Pharmaceutical product development. Biologics Consulting has extensive experience in providing successful advice on regulatory, product development and quality systems, to manufacturers of biologic products.

Our team brings decades of experience at every stage of the biologic regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, quality management, product manufacturing, medical device biocompatibility, clinical trial design and evaluation, immunogenicity assessment, statistics, GTP, GMP, GLP and GCP regulatory compliance, and U.S. Agent Services. Our knowledge and hands-on experience in hundreds of successful applications and regulatory submissions, including BLAs, 510(k)s and INDs spans the full spectrum of biologic product development pathways. Our breadth of experience allows us to develop comprehensive strategies and product development plans to position clients for successful product outcomes and regulatory approvals. Biologics Consulting is proud to offer more than consulting services and regulatory support to our clients by providing a full scope of biotech product development consulting services. Our expertise extends from product development and manufacturing to GLP/GMP consulting, clinical trial management and BLA submission support services. In short, we are your success partner at every point in the product development continuum for your biologic product.

Our mission is to provide guidance and value at every step of the biologic product development process, from conception to clinical trials to commercialization. Regardless of the current stage of your product development, the Biologics Consulting team brings the scientific knowledge and industry experience necessary to step in and provide hands-on assistance to your team.

Biologics Consulting has extensive experience in providing regulatory, product development and quality systems consulting services to developers and manufacturers of pharmaceutical products.


Our team of consultants brings decades of experience in quality management, regulatory affairs, product manufacturing and testing, pharmacology/toxicology, clinical trial design and implementation, statistics, and GMP, GLP and GCP compliance. For each engagement, we leverage our knowledge and hands-on experience in creating product development pathways and maneuvering through the relevant nuances to position our clients for successful outcomes and regulatory approvals.

Every Step of the Way: Biologics Consulting's Biologic Expertise

1
Our consultants will collaborate with your team to assess your product development plan, identify the appropriate pathway for approval, define all applicable scientific and regulatory requirements, and craft a customized product development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization.

2
Biologics Consulting will work with your team to manage preliminary testing, provide hands-on leadership at meetings with the FDA, OBA, RAC advisory committees as well as support your regulatory submission to ensure the best possible submission.

3
Once your IND application has been submitted to the FDA, Biologics Consulting will provide your product development team with advice every step of the way during the IND review process. Our consultants leverage their unique “insider” perspective to interpret Agency requests and communications as well as to provide guidance on the latest Agency thinking, positioning your new product for a successful outcome. Our team prides itself on quickly and accurately interpreting Agency requests and comments, eliminating the guesswork and costly delays that plague many Agency interactions.

4
Once an IND is allowed to proceed, the clinical stage of development begins. During this stage, the Biologics Consulting team supports your clinical trial efforts with quality/CMC and clinical consulting services customized to your product. From designing Phase 1 protocols to the oversight of clinical trials conducted by CROs, to a “FDA-type” review of data generated by Phase 3 studies, our clinical team brings scientific insights, medical and clinical operations knowledge and industry experience necessary to ensure your trials are successful and part of an efficient overall regulatory strategy.

5
In addition to our expertise in nonclinical, clinical and quality/CMC consulting, Biologics Consulting also has a team of experts in product manufacturing and testing requirements for biologics – knowledge that we leverage to boost your chances of a successful BLA application. Successful applications that require GLPs and GMPs are strictly adhered to throughout every step of the application process to ensure every sample is substantially equivalent, safe and effective. The Biologics Consulting team brings decades of experience in all aspects of testing, manufacturing, storage, and distribution, so you can rest assured that all aspects of your operation are fully compliant with FDA regulations.

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With more than 75 successful BLAs/NDAs (full and supported) submitted in the past four years, the Biologics Consulting team is well positioned to assist your organization in preparing and submitting your BLA. During the application process, we provide hands-on support, leadership at Agency meetings and guidance in interpreting CBER, CDER and CDRH interactions. Our team can help translate raw clinical data into a compelling story that will resonate with FDA reviewers, evaluate labeling options and review marketing collateral to ensure accuracy, compliance and the best possible outcomes for your submission.

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Once your product has been licensed and is ready to go to market, the Biologics Consulting team is able to provide assistance in overseeing manufacturing and quality control, drafting required periodic safety updates for the FDA and assisting your team through additional development and commercialization processes, including re-positioning the FDA application for international regulatory approvals.