Biologics Consulting has extensive experience in providing regulatory, product development and quality systems consulting services to developers and manufacturers of pharmaceutical products.
Our team brings decades of experience at every stage of the pharmaceutical 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, statistics, GMP, GLP and GCP regulatory compliance, and U.S. Agent Services. 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.
Biologics Consulting is proud to offer more than consulting services and regulatory support to our clients – once we are on-board, we view ourselves as your success partner. Our mission is to provide guidance and value at every step of the drug development process, from conception to clinical trials to commercialization. Regardless of the stage of your product’s development, the Biologics Consulting team brings the scientific knowledge and industry experience necessary to step in and provide hands-on support to your team.
Every Step of the Way: Biologics Consulting’s Pharmaceutical Expertise
Biologics Consulting will collaborate with your team to assess your product development plan, identify the appropriate pathway for approval, define all applicable regulatory requirements and craft a customized product development strategy that minimizes time to clinical trials and regulatory approval.
Biologics Consulting will collaborate with your product development team to manage preliminary testing, request, prepare for and attend meetings with the FDA and other key stakeholders, as well as assist in the completion of the IND application for your new product.
Once your IND application has been submitted to the FDA, Biologics Consulting will support your product development team with advice every step of the way through the IND review process. Our consultants leverage their unique "insider" perspective to interpret Agency requests and communications as well as provide guidance on the latest FDA thinking, thereby positioning your new product for successful outcomes.
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.
In addition to our expertise in nonclinical, clinical and quality/CMC consulting, Biologics Consulting also employs a team of experts in product manufacturing and testing requirements for all classes of pharmaceuticals - knowledge that we leverage to bolster your chances of a successful ANDA or NDA application regardless of the development pathway. The Biologics Consulting team, together with your product team, will ensure that all aspects of testing, manufacturing, storage, and distribution are fully compliant with constantly evolving FDA regulations.
With contributions to more than 75 new 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 marketing application, regardless of pathway. During the application process, we provide hands-on support, preparation for Agency meetings and guidance in interpreting feedback from CDRH, CDER and CBER. 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 outcome for your product's application.
Once your product marketing application has been approved and your product 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 throughout the product lifecycle and commercialization processes, including re-positioning the FDA application for international regulatory approvals.