Company Profile | April 23, 2001

Bio-Development Consulting Services

Source: Bio-Development Consulting Services
Expertise in Biotech Product & Business Development

Bio-Development Consulting is a comprehensive resource for individual researchers, companies or universities seeking to implement or commercialize new developments in biotechnology, anywhere in North America.

Combining up-to-date knowledge and in-depth experience of the biotechnology industry with strategies for product and business development and regulatory compliance, Bio-Development Consulting bridges the gap between biotech innovators and the commercial environment.

Bio-Development Consulting provides a comprehensive range of services for new biotechnology companies and more established operations planning expansion or moving from research/development to clinical evaluation and beyond and for university researchers seeking to commercialize new discoveries.

WE OFFER:

TECHNICAL SERVICES

  • Technology Evaluation for Innovative Content and Commercial Potential
  • Process Evaluation, Scale-up Procedures and Cost Improvement Proposals
  • Computer-based Project Planning and Control
  • Design, Construction Supervision, Commissioning & Validation of Pilot and Main biotech manufacturing plants, to comply with international current Good Manufacturing Practices legislation.

    REGULATORY SERVICES

  • In-house GLP/GMP Staff Training with Follow-up Evaluations to ensure compliance
  • Establishment of Quality Assurance Programs
  • Preparation of SOP for GLP, GMP compliance
  • Creation of other Regulatory Documentation
  • GLP/GMP Audits and Reports to FDA standards

    COMMERCIAL SERVICES

  • Preparation of: Market Analyses
    • Marketing Plans
    • Overall Business Plans

  • Identification of Partners and Negotiation of Agreements for:
    • Strategic Alliances
    • Collaborations
    • Licensing-In/Out.

  • Assistance with recruitment of senior executive and scientific staff from North America.

    DR. ALEX D. KANAREK, PhD BSc MCIM
    President & Managing Partner

    Dr. Kanarek has had over 30 years of wide-ranging experience in all aspects of the research, development, manufacture and marketing of biopharmaceutical and bio-diagnostic products. This has included liaison with Universities, the identification and evaluation of new business opportunities, the design and construction of manufacturing facilities in the UK, Canada and Pakistan and the professional management of fully integrated project teams handling product development and market launch. He has served as a member of the Steering Committee of BIONET Canada and the Council of the Toronto Biotechnology Initiative.

    He is the author of "A Guide to Good Laboratory Practice for Laboratories in Academia and Industry", "The Bioprocessing Industry, an In-depth Review", "A Guide to Good Manufacturing Practice for Start-up and Developing Biopharmaceutical Companies" and "A Guide to Good Clinical Practice".

    Since 1993, the Consultancy he heads has worked with established and start-up companies to prepare new business plans, improve product planning and provide training in regulatory compliance for research, development and pilot manufacturing facilities and staff. Two of their most recent projects involved 1) the design, construction, commissioning, staffing and supervision of an 11,000 square foot facility for a new US company developing novel vaccine and drug delivery systems and 2) the equipping, staffing and project management of an incubator laboratory facility for a new start-up company specializing in immuno-therapeutics.