We invite you to read feedback from Our Clients
“I’m so pleased with the level of support, knowledge, communication skills, and prompt response she has with requests from Latin America. I’m very happy with her work....she is excellent!”
Pfizer Regional Director Regulatory Affairs, Latin America
"We use the manual you created for us often, you have no idea how much we appreciate that effort!"
Johnson and Johnson Senior Director Regulatory Affairs
“I wanted to let you know that your presentation was OUTSTANDING!! Nice work!! You were clear, organized, listened well, provided strategic leadership, pushed for timelines when needed. I am thoroughly impressed.”
Stiefel Laboratories VP Global Clinical Research and Regulatory Affairs
“...I highly recommend as a Regulatory CMC Consultant. You have a great breadth of knowledge. You addressed issues quickly and took initiative to generate and implement solutions. Worked independently and quickly. A key member of our team and has contributed to our success."
Millennium Pharmaceuticals Associate Director Worldwide Regulatory Affairs
"Please know how much I appreciated all you did for us. It has been an honor to work with you again. I must thank you in all ways possible. You came here and started making a difference from day 1. Your insight, experience and perspective have taught us much. We all benefited. Thank you so much."
Shionogi Senior Director Regulatory CMC
“We recently wrapped up an important phase of bringing <Product X> to Japan, and I'm writing to thank you for your contributions to that question and answer period. Your collaboration and contributions helped AZ successfully support this next phase of expanding access to <Product X> to patients in need. Thank you for contributing your expertise and time! “
AstraZeneca Senior Director Site Quality Lead
"I very much enjoyed working with you. You have contributed significantly to progress of our project...Your very thorough approach will be missed."
Merck and Company EMEA Network Action Lead
“…Deeply committed to meeting the needs of…customers and…displayed a constant focus on customer satisfaction. …actively listens to customers/colleagues and seeks information to help resolve issues/meet their needs. …practices high work standards to deliver high quality work while maintaining or exceeding established department workflow timelines to meet business needs. …adapts well to the organization or group… joins, picking up work practices/processes with ease, while providing for timely and constructive feedback to enhance processes, when necessary. Overall, if identified for completion or management of a task.…gets the job done efficiently and completely. …inviting personality and approachability only adds to…professionalism, technical abilities, and experience. …someone you want on your team.”
Pfizer Senior Manager/Team Leader Global Manufacturing Compliance
"...has worked with me for 8 months on a new NDA. I am extremely pleased with her work and high integrity. I admired her high energy and drive. She is clearly a leader, hard worker, and excellent project manager with vast Regulatory CMC knowledge, most importantly, easy to work with, and has positive attitude under all situations. she is thorough and efficient, she gets things done so quickly that force you to keep up with her pace. I truly enjoyed working with her."
Takeda Cambridge USA, Director Regulatory CMC
"...providing Regulatory support to this effort and has been a key team member. I find myself consulting with on Regulatory and Quality related issues...provided concise and timely information and advice. I have been impressed with general knowledge, teamwork and overall professional approach in supporting this important project...very nice person and I would not hesitate retaining services in the future"
Merck and Company Manager External Contractor Management
“...Worked very diligently and conscientiously on processing complex change controls for my group. ...very focused and persistent and brought a well-developed Regulatory and Compliance skill set. ...worked very quickly and strove to put out a high quality product. I would work with ....again in the future if the opportunity arises.”
Pfizer Director/Team Leader CMC, Biologics, Device & Veterinary Vaccines
“Please accept my sincere thanks for all you both did for the department and for me personally. It has been my pleasure and honor to work with both of you"
Pfizer Director/Team Leader Global CMC
" I really appreciate everything you are doing, you are such a huge help and support to me and I'm so thankful for you."
ModernaTx Vice President CMC Regulatory Affairs: Personalized Cancer Vaccine
“...Worked in our department for several years and successfully and efficiently managed several complex and key products. One was an older product that required a great deal of remediation and handling...worked with all the international stakeholders to facilitate any work that was required, and negotiated the strategies that would be used. I worked with on several complex sterile product changes and found to be very detail oriented, thorough and a pleasant professional colleague that I would recommend.”
Pfizer Senior Manager Global CMC
“...is a conscientious individual contributor, as well as a team-oriented professional... was deeply committed to meeting performance deliverables in the Regulatory CMC arena...multitasks well, ensuring adherence to business practices and regulatory requirements when processing global CMC post approval regulatory changes and when providing dossier maintenance support for license renewals, completion of U.S. Annual Reports and heath authority queries, as well preparation of dossiers for line/territory extensions. A congenial personality, approachability, and focused attention to work activities are additional assets of this accomplished professional...can be relied upon as a positive, productive member of any team.”
Pfizer Director/Team Leader Global CMC
“Provided clarity, guidance, and impetus on a submission strategy...you displayed... a good attitude, Encouraged open discussion and debate, Focused on the customer, and were there for us."
Pfizer Manager in WRS International
"Thank you for all of your great work and support on the ... Program. Although it is a cliché, in this case it is very true: We could have not done it without you."
Millennium Pharmaceuticals Associate Director Worldwide Regulatory Affairs
"You've been such a great colleague, very supportive, accommodating and understanding."
Pfizer Regulatory Officer, Philippines
"You have been a key player on the <compound> program collaborating cross-functionally and your dedication, support and patience will definitely be missed. Thank you for all your contributions..."
Shire Senior Director Global Regulatory CMC
“I really appreciate what you’ve done on the contract project and the Third Party support.”
AstraZeneca Senior Director Regulatory CMC Commercial Biologics
"I can honestly say, that it was a pleasure working with someone as intelligent, smart, organized and focus oriented like you."
Merck and Company Regulatory Scientist Network CMC
“...thanks for your continued very professional support.”
Pfizer Senior Director Quality Operations Leader Established Products
“You were always so great to work with and I knew that I could always count on you for a thorough understanding of any situation that we found ourselves in the middle of.”
Pfizer Principal Scientist Regulatory
“One of the most efficient GMC contacts I’ve known.”
Pfizer Senior Specialist Quality Operations
"It's been a pleasure working with you and I greatly appreciate all your contributions and support over the years (as well as the level of professionalism you bring to your role)."
Takeda Program Management Leader
“...thank you for all the updates and work done to Module one (1) and other topics. I value your input and management of all the details pertaining to the content of the ANDA."
General Electric Healthcare Head of USCAN Regulatory Affairs, Core Imaging
"I wanted to say Thank You for the 'additional' IND Amendment support in <colleague's> unforeseen absence. Greatly appreciate the Efforts!!!!"
Shire Associate Director Combination Product Device Development
