I have worked with Diana Goldman and her team for many years. The first time I engaged with Diana, she was very up-front regarding her oversubscribed personal bandwidth. However, since she understands project requirements, she was able to provide appropriate support through one of her associates. The overall services provided were at the highest level and the overarching message is that Diana does not compromise on quality services – even when she is not directly involved in the day-to-day.
As additional QA needs were identified by my various clients, I continued to bring her in for support. Through these activities, I have worked directly with Diana as well as with at least 6 additional members of her group. The Diana Goldman Consulting group is now my go-to resource as Diana, and her team, are extremely easy to work with, highly professional and knowledgeable and exceptionally responsive to all client QA needs for CMC, Clinical and preclinical as well as other areas. I will continue to recommend Diana and her team to my clients as well as others requiring assistance in clinical development. I really don’t know how I managed before working with her.
Daniel L.
Owner and Principal Consultant
We have worked with Diana Goldman Consulting for over a decade. Diana has managed the Quality Assurance and other related matters for our firm infallibly. She is fully dedicated to helping us resolve our needs across numerous areas including the successful move of our manufacturing processes from one CMO to another as a post approval change. Diana takes ownership of the projects for which she is hired, and her detail-oriented nature ensures all issues are addressed in a timely fashion.
Perhaps the greatest benefit of working with Diana is that she has a deep network of highly experienced and skilled industry experts at her disposal. I highly recommend her services to any company big or small, as she will always deliver on any undertaking entrusted to her!
Edwin H.
CEO
Diana Goldman Consulting, Inc. has provided me with high-quality consultants for over 20 years. The company has provided me with experienced people for manufacturing and analyticalbatch reviews, document control, and for the conduct of audits of just about every GxP function.
I don’t know what I would do without DGC when I’ve needed auditors for specialized areas such as toxicology, bio-analytical, and data capture systems, or when I’ve needed GMP audits conducted in remote areas of China or India. Diana and her team have always come through for me when I’ve needed assistance with just the right person and reasonable rates that a small company can afford.
Charisse E.
Senior Director/Head of Quality
I have known Diana for about 10 years. Working closely with the CMC members, she performed at her job very effectively establishing and executing the function according to global quality requirements in support of multiple clinical programs in different phases of development.
Diana has a comprehensive understanding of her area of expertise. She is able to work with her CMC, Regulatory and others on the timely resolution of complex problems and according to established timelines. Diana is well known as a Quality expert in the local pharmaceutical industry, and she is often sought out by small and medium size companies. One of the many Diana’s attributes is her ability to convey and establish the required quality requirements appropriate with the program development phase and establishing at the same time the additional requirements that will be necessary to develop and implement as the program progresses towards commercialization.
Diana engages with openness, responsiveness, empathy, enthusiasm, respect and friendliness.
Rafael S.
Sr. Director, CMC
Diana and her network of consultants are a pleasure to work with and provide development-stage appropriate support working with her clients to efficiently meet the needs of development programs from IND submission through NDA and commercial launch.
I’ve worked with Diana and her team over the last 10 years from biotech startup through Phase 3 and NDA preparation. She has set up the Quality department and documentation for me at 2 companies and scaled the QA systems as the companies grew and entered late-stage development. Diana has a depth and breadth of program experience to troubleshoot manufacturing issues, provide practical CAPA oversight and plan for the strategic needs of fast-paced clinical programs. I can highly recommend Diana and her consulting network as competent, high-performing, and professional resources.
Allan W.
CTO
I have worked with Diana Goldman and her team for almost 20 years on a number of CMC projects. I have found Diana’s QA expertise to be invaluable. Her many years of experience as an independent consultant allows her to provide valuable insight and advice drawn from trials and tribulations with different technologies and various clients as well as CMOs through the years. Even more impressive is her breadth of knowledge in related technical areas which provides for an interdisciplinary “Quality” perspective that is rarely available from other QA experts.
Diana has always been very responsive and dedicated to the timely completion of assigned tasks and achievement of team goals. The Goldman team of industry experts are experienced and perform at a high level.
I have been very pleased with the services of Diana and her team and highly recommend them.
Bert H.
Head of Pharmaceutical Development
I was eagerly looking for high-quality CMC consultants to support our pipeline 6 years ago. I was lucky to be connected with Diana Goldman Consulting Inc. Since then, I have been working with three consultants from the company. They provided superior CMC and Quality services and made instrumental contributions to our company’s success. Diana harnesses her broad network to identify top-notch CMC consultants and associates to support her clients’ needs. I highly recommend her company and services to any small and medium size biotech companies.
Xin L.
Vice President, Head of CMC