BCG Offers Regulatory and Product Development Support for Biologics, Drugs and Medical Devices

BCG Strengths

• Unique combination of FDA, biologic, drug and medical device industry experience
• Extensive experience with biologic, drug and medical device development issues, including preclinical pharmacology-toxicology, manufacturing and testing, and clinical development
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• Extensive experience in preparation and/or review of regulatory submissions including pre-IND meeting packages, INDs (paper and electronic), IDEs, 510(k)s, BLAs/NDAs /PMAs (electronic traditional and CTD formats), Master Files, Orphan Drug Applications, etc.
• Able to provide expert advice on a broad range of pharmacology-toxicology issues associated with U.S. and international approval of biopharmaceutical products
• in depth knowledge and understanding of FDA expectations and regulations

Product Experience

• Vaccines
• Therapeutic Proteins
• Cytokines/Interferons
• Monoclonal Antibodies
• Blood Products
• Gene Therapy Products
• Cell and Tissue Products
• Devices and Diagnostics Products
• Allergenic Products
• Peptides and Small Molecules
• Bacterial and Viral Therapies

Regulatory Services:

• Regulatory/scientific assessment (gap analysis) of biologic, drug and medical device products and processes
• Development of Product Development Plan (PDP)
• Development of regulatory strategy
• Preparation/Review of pre-IND briefing documents
• Pre-IND meeting preparation and post-meeting review
• Design/Review of preclinical pharmacology/toxicology studies
• Design/Review of Chemistry, Manufacturing, & Control (CMC) plans/processes
• Screening and oversight of CTOs (Contract Testing Organizations)
• Manufacturing process evaluation and optimization
• Identification and screening of CMOs (Contract Manufacturing Organizations) and oversight of product manufacturing
• Development of Clinical Development Plans (CDP); clinical protocol and Investigator Brochure development/review
• Clinical study Request for Proposal (RFP) preparation
• Screening and oversight of clinical CROs (Contract Research Organizations)
• Regulatory submission (e-subs capability)
• GMP/GLP/GTP/GCP audits
• U.S. Agent services

Product Development Services:

Whether you need limited assistance with a manufacturing or analytical testing issue, or comprehensive oversight/management of your complete product development, BCG has the expertise to provide you with the specific assistance you need.  Because we are uniquely familiar with FDA expectations and requirements for all types of biologic, drug and medical device products, we are able to design streamlined, cost-efficient product development pathways which are fully compliant with FDA regulations.

Pre-IND/IND/IDE Support:

• Gap analysis and regulatory/scientific assessment of product
• Strategic advice on development
• Guidance on interactions with regulatory agencies
• Planning and conduct of pre-IND, end of phase I and II, pre-BLA submission meetings
• Preclinical assessment of pharmacology studies
• Preclinical toxicology study design, Contract Study Organization (CSO) selection and ongoing management and review, and review of study reports
• Clinical evaluation and preparation of Clinical Development Plan (CDP), study design, protocol and Investigator Brochures (IB) preparation
• Phase I study site Request For Proposal (RFP) preparation, site selection and study management
• Identify manufacturing strategies and provide Chemistry, Manufacture and Controls (CMC) guidance on requirements.  Identify and select Contract Manufacturing Organizations (CMO) and oversee the manufacture of the product
• •     Provide an overall project management team-work approach to manage and oversee the delivery of a successful IND submission
• •     Preparation/review of pre-IND briefing document and IND submission
• •     Request for Orphan Drug Designation
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BLA/NDA/PMA Support:

• BLA/NDA/PMA evaluation/preparation (electronic traditional and CTD formats)
• Pre-BLA/NDA meeting preparation and post-meeting review
• Process validation review/preparation
• Pre-Approval Inspections (PAI)

Outsourcing and Project Management Support:

In support of your overall program development, BCG can also help to identify and manage qualified manufacturing, nonclinical and clinical vendors suitable for any biologic project.  Once your plan is underway, we can assist with:

• Vendor identification and qualification
• Design of manufacturing and nonclinical safety programs
• Placing and managing both manufacturing, and nonclinical development projects
• Program oversight and appointment of a program manager
• Budget and Timeline Tracking