Weissinger Solutions, Inc. (WSI) provides full service regulatory and quality assurance consultation, and teaching and contract services to the pharmaceutical, biotechnology, cosmetic, food supplement, animal drug and medical device industry. Under the direction of Dr. Judi Weissinger, Ph.D. (short biosketch attached), WSI is uniquely qualified to provide regulatory strategies and solutions in all areas regulated by FDA. In addition to developing and submitting regulatory documents, WSI advises on the
Pre-IND strategy and filing,
     filability and acceptability,
          pharmacology/toxicology,
               formulation changes,
               excipient evaluation,
                    aerosol products,
                         changes in route of administration,
                              drug device combination products,
                                   interspecies extrapolation,
                                        crisis preparedness/management,
and strategies for rapid advancement of novel molecular and biological entities into clinical trials. WSI has served over 300 satisfied clients in the last 10 years. All regulatory requests for marketing and advisory committee presentations developed and coordinated by WSI have been successful. Over 100 pre-IND/pre-IDE meetings have successfully achieved FDA buy in and significant streamlining in development programs resulted. Only one clinical hold occurred in over 100 INDs and it was readily resolved. WSI is well known for providing rapid assessment, effective solutions, and negotiation strategies that present successful outcomes for FDA and the regulated industry.