Consultant Expertise
Our success lies in the experience, values and innovative thinking of our consultants. Our Senior Consultants, along with our deep network of Regulatory Affairs professionals, stay ahead of the curve and provide you the expertise required to negotiate Pharmaceutical, Biotech, Generic and Medical Device approvals and also develop regulatory strategies for these products. A summary of some of our consultant expertise is listed below.

  • Over 25 years of industry experience. A highly innovative individual with proven ability in Strategic and Operational Regulatory Affairs Management, Project Management, Drug Development, Medical Research and enterprise corporate business and systems re-design initiatives, within large and small pharmaceutical/biotech/generic companies. A proven ability to lead, problem solve, create practical and cost effective solutions, for international and national drug development organizations.

     

  • Has established functional groups for top tier Pharmaceutical and Biotech organizations that have been responsible for submitting thousands of dossiers annually to worldwide regulatory agencies. Transitioned organizations at an enterprise level (all functional business units) in developing processes and systems that have reduced the time it takes to create and submit marketing applications, and post marketing submissions, from first time in man (Phase I) to commercial launch and post marketing activities (Phase III – IV).

     

    Specialties

  • Regulatory Affairs, Regulatory Operations, Project Management, Clinical Strategy/Operations, Enterprise System/Process Re-Design for Regulatory Compliance Systems, Organizational Re-Design, Identifying Process Efficiencies for Rapid Drug Development.

 

Senior Consultant

  • Brings to the table 35 years of experience in the pharmaceutical/biotechnology industry the past 27 as senior regulatory affairs professional.

    Among his accomplishments are a series of "firsts" including: a Treatment IND, Orphan Product and Pivotal Trial Status and a Compassionate Use Protocol with cost recovery for an autologous cellular therapy and Pivotal Trial Status for a xenogeneic bioartificial liver.

     

  • He has had extensive dealings with CBER, CDER and CDRH at the U.S. Food and Drug Administration. Internationally, he has worked with the Bureau of Biologics and Radiopharmaceuticals of the Health Protection Branch in Canada, the Medicines Control and Medical Devices Agencies in the UK, and The Paul Ehrlich Institute in Germany. These activities have resulted in the allowance of international clinical trial applications, as well as the approval of five very different biopharmaceutical, cell and tissue processing and vaccine manufacturing facilities.

     

    Specialties

  • FDA and Foreign Regulatory Authority Interactions, Meetings: Pre-IND/IDE, Pre-BLA/NDA/PMA , GMP/GLP Issue Resolution, Product Development & Approval Strategy Planning, Submission Theory and Design, Facility Design and Approval, Regulatory Function Development, Preclinical Program Design, Clinical Trial Implementation, Due Diligence Reviews.

 

Thank you for reviewing the page.  We only highlighted a few of the many consultants we have available, so if you are looking for any additional skills not highlighted in the consultants we listed above, please don't hesitate to contact us.