Translational
“Today’s preparation determines tomorrows achievement”
Getting an idea out of the research laboratory and into a viable commercialized product is difficult and requires expertise that most academically trained scientists do not have. We advise investigators from preclinical stages of development, with emphasis on refining the clinical indication and the scientific and regulatory requirements related to product development, such as manufacturing, safety testing, animal models, analytic methods, pharmacokinetics, biomarker assay development and validation.
Development, Manufacture and Trouble shooting
“Quality is never an accident”
We provide consulting in the development and implementation of a quality platform necessary to manufacture new technologies. This includes creation and implementation of new standard operating procedures (SOP), SOP manual, batch records, quality management plan, validation plan, hiring and training adequate staff, troubleshooting technical runs, validations and manufacturing process
Regulatory
“We cannot direct the wind…but we can adjust the sails”
We are here to help you navigate through the US regulations to bring a safe product to the market.We are accountable for keeping up pace with the increasing complexity as well as the scope of the regulatory policies and guidelines. Our consultants assist with interpreting the laws and regulations for our customers. We can establish registrations and product licensing with the U.S. FDA, acting as a primary link between our client and the regulatory agency. Our consultants act as an extended team member on project teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle. We provide guidance and/or perform preparation and submission of routine regulatory applications, as well as internal regulatory file documentation and assist with developing and maintaining positive relationships through oral and written communication regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
Do not hesitate to contact us
To discuss more about our capabilities and services, please contact us via e-mail at [email protected], or call our offices at (713) 328-6913. You can always mail us at ATAB Consulting, LLC. 1001 Texas Avenue. Houston TX 77002. USA.