LODAAT or ” Live One Day At A Time” is an American science based firm founded in 2007 with the objective to provide the world’s best generic pharmaceuticals, innovative high value molecules OTC, VMS, nutraceuticals, and botanical ingredients.
Our quest to research health and wellness therapeutics has resulted in unique formulations, patented manufacturing processes, and proprietary programs.
The paradigm shift of implementing US technology with the leading global partners is a scientific methodology that has been the inspiration behind LODAAT.
We are committed to advancing healthcare through innovative pharmaceutical solutions. Our team of dedicated scientists and researchers work tirelessly to develop and deliver safe, effective treatments that address some of the most pressing medical challenges of our time.
LODAAT MASTERCLASS Frankfurt, Germany
Our Science Team and affiliated partners have over 25+ years business experience in Pharmaceutical manufacturing processes, and Regulatory Affairs having created over 50+ CTD dossiers for over 30 countries and 360 product formulations. Our Team is responsible for compliance activities of all API and successfully managed a number of DMF filings with US, Europe.
Our experienced regulatory staff is experienced in Global Regulatory affairs with USFDA, UKMHRA, INVIMA, WHO-GMP, EU-GMP, TGA, GCC-MOH and other regulated market standards. Our expertise is in Quality Assurance, Quality Control, Microbiology and Research and Development of Fermentation. Our team includes Medical Doctorates with postgraduate in internal medicine, expertise in pharmaceutical manufacturing, and leadership in formulation development.
Our professional Operations team has 15+ years experience in manufacturing Ingredients, small molecules, and international project management. We believe in thinking creatively and to ensure that our production and operations meet customer needs. We are familiar with strict timelines and deadlines for the pharmaceutical industry and are actively involved in interfacing with the marketing and supply chain management team.
Our 5-member Business Development team consists of professionals in the legal, strategy, and sales verticals. We understand In-Licensing, Out-Licensing and registrations for the US, and global markets. From US ANDAs, emerging market Pharma submissions, nutraceutical formulations, or clinical trials, we have the experience to get deals done.
LODAAT’s priority always has been the quality of its products. An integral part of this is our rigorous in-house and third party testing, technical documentation and support that we provide to our global partners. LODAAT has invested earnestly in this sphere and we have a full fledged team of Regulatory Experts preparing Dossiers conforming to national and international regulations in various formats including dossiers in CTD/ACTD formats and DMF filings. We have requisite infrastructure & expertise to ensure proper regulatory approvals of our clients and on-site pre-approval inspections by competent agencies like the U.S. FDA, NHRA, SAUDI FDA, EDQM, and more. Through our partners, we have more than 25 ACTD / CTD Dossiers.
Our strategic plan includes an emphasis on quality management systems, periodic reviews of quality systems, and reviews of the process toward achieving quality objectives.
All documents being generated are highly controlled and archived according to international standards. Well-defined process controls and procedures are the keys to achieving quality documentation and ensuring qualitative output. We strive to meet all pre-determined specifications consistently.
Our field experts possess a well defined regulatory affairs structure managed by highly qualified & experienced experts in this field. We have the capability to develop and file CTD DMF, US DMFs, COS and other registrations required in various markets.
The implementation of corrective and preventive actions concluded from and investigation are closely monitored by the quality assurance team. LODAAT has a well established system for handling customer complaints. This is illustrated via a step-by-step procedure, right from log in of customer complaints until its resolution.
