Client Testimonials

Lois and Steve Rosenberger have done multiple projects for Wyeth and specifically for the Women's Health and Tissue Repair group. They have been outstanding in their commitment, quality, and attention to detail. They are there when you need them and do not prolong a project if not needed. I can think of no better team when extra help is needed.

I have had the pleasure of knowing Lois and Steve Rosenberger since 2001.

Lois, Steve and their staff at LBR Regulatory and Clinical Consulting Services, Inc. have been instrumental in the clinical development, clinical operations & monitoring, initial regulatory strategy & documentation maintenance, IND correspondence, FDA meeting attendance, investigator meeting conduct and program & site management services related to Xanodyne's XP12B-MR Juno Clinical Development Program.

Specifically, LBR led by Lois & Steve, provided insight into the phase III clinical protocol development, managed the CRF development process (including PRO & diary forms generation), identified potential sites & negotiated the clinic contracts, and provided the clinical execution & monitoring services for Xanodyne's first in class, heavy menstrual bleeding (menorrhagia) management therapy.

A unique attribute of LBR is their uncanny ability to hire the best, most experienced clinical and professional staff, which they develop further to maximize the individual's potential and talents, and hand off to them the most appropriate clinical, operations, and/or monitoring activities within a clinical/regulatory program in order to optimize the organizations' efficiencies and effectiveness!

Leading well is not about enriching ones' self, rather it's about empowering others, and Lois and Steve live this philosophy everyday! LBR brings the regulatory and clinical knowledge, experience, character, ability, relationships and previous success to influence a positive outcome on any new development program or a program that needs to be salvaged!

As a small start-up company we have used LBR in just about every area of drug development and appreciate the flexible and tailored attention and "know how" support we get.

Thorn BioScience has relied on LBR Regulatory for over 10 years. We have always found LBR to be knowledgeable, available and their rapport with the FDA to be unsurpassed.

The expertise and knowledge that LBR shared truly helped us accomplish our goals in IND preparation and Orphan Drug submission. We were very impressed by LBR's speed, thoroughness, professionalism, and especially dedication to our project – it was as if their team was an extension of our company.

LBR provides excellent service at a reasonable cost. Highly qualified personnel able to deliver quality products in a timely manner, e.g., provided complicated IND in eCTD format to meet aggressive timeline. Small group that has the flexibility to meet customer's needs. Highly recommended.

LBR was a dream team to work with. They always delivered high quality product on time. The entire team was extremely knowledgeable and someone was always available to discuss questions that we had on a very complicated eCTD. I hope to work with them again in the future.

Bottom Line is that LBR Regulatory has delivered high quality work on time for very aggressive Clinical Programs.