The Biologics Consulting Group, LLC

section heading graphic   Overview

The Biologics Consulting Group, LLC (BCG) provides regulatory and product development advice and assistance to biotechnology companies and research institutes developing biopharmaceutical products.

For the US, we offer regulatory assessment of products and platform technologies, strategic advice on development , guidance with regulatory agencies, planning, review and preparation of pre-IND meeting requests/information packages, INDs, BLAs, Master Files, Orphan Drug Applications.

We also offer advice on the biopharmaceutical product manufacture and selection of Contract Manufacturing Organizations (CMOs), preclinical pharmacology/toxicology and study site selection, overall clinical development strategy and early phase clinical trial design and study site selection and management as well as overall project management. We also offer GMP support and GMP/GLP inspections and can act as the US agent for foreign companies.

Our product experience includes Vaccines, Therapeutic Proteins, Monoclonal Antibodies, Blood products, Cell and Tissue products, Gene Therapy, Allergenic products and Devices and diagnostic products.

section heading graphic   Competitive Advantages

BCG offers a unique understanding of FDA and international regulatory expectations. Many of our consultants are former FDA reviewers, certified inspectors and industry experts. Jim Kenimer, PhD, founder and president of BCG, was the Deputy Director of the Division of Vaccines and Related Products Applications (DVRPA).

section heading graphic   Technology/Services

Pre-IND/IND Services

  • 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 management, 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
  • Orphan product application

GMP Services

  • GMP/GLP/GTP inspections
  • Review of facility plans
  • SOP review and preparation
  • Validation program review
  • Pre Approval Inspection (PAI/PLI) readiness assistance

BLA Services

  • Application evaluation/preparation
  • Process validation review
  • Manufacturing issues review
  • Assistance in planning the pre-BLA meeting

US Agent Services

  • U.S. Agent for Filing an IND, as described in 21 CFR 312.23(a)(1)(ix), for non-U.S. biological manufacturers
  • U.S. Agent for Establishment Registration and Listing

section heading graphic   Corporate Alliances/Partnerships

N/A

Contact Person Jim Ackland Biologics Consulting Group Logo
Job Title VP West Coast and Asia Pacific Operations
Address
Level 50,
101 Collins Street
City/Suburb
Melbourne
Victoria 3000 Australia
Email
jackland@biologicsconsulting.com
Phone +61 3 9653 9632
Fax +61 3 9653 9307
Website www.biologicsconsulting.com

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