QUALITY SYSTEMS

Randall Tlachac, President 

 

 

Our mission is to provide the highest level of cost effective service, leading to the earliest approval of novel therapeutic products and delivering systems which provide the highest level of quality and value.

 

With over 30 years of experience in quality, manufacturing and commercial development of biotherapeutic, biotechnology and pharmaceutical products, medical devices and combination products, our expertise focuses on compressing product development timelines, successfully bringing products to market while implementing effective quality systems to assure compliance with regulations and conformance with requirements.

 

Mr. Tlachac has experience with development of sterile injectable pharmaceuticals, solid oral dosage forms, fermentation-based and plant-based biopharmaceutical products, combination drug/devices, as well as peptide-based vaccines,  biotherapeutic cell-, gene- and tissue-based products, probiotics and medical devices.  He has extensive experience in the development and commercial manufacturing of pharmaceuticals, medical devices, including capillary dialyzers, intravenous sets, filtration products, drug-coateed stents and plasmapheresis bioreactors. 

 

Tlachac has lead the development and expanded Translational Research capabilities at 4 major universities and medical research institutions  across the United States, providing support and direction of over 30 INDs for stem cell and related cell therapies, monoclonal antibodies, peptides, fusion proteins, pancreatic islet transplantation and small molecule drugs.  In several instances, the creation and implementation of GMP development capabilities within research core groups has been a central driver to enable the advancement of drug development within academic and research institutions.

 

Mr. Tlachac has held senior roles for the development and manufacturing of biotherapeutic and pharmaceutical products. He has implemented industry-best practices for product development processes, ISO-based quality systems and risk management systems which assure the earliest delivery of novel therapeutic products to patients in clinical research sponsored by major research institutions and start-up firms.  

 

His prior experience at major firms including Boston Scientific, DuPont Pharmaceuticals, Baxter Healthcare and leading institutions such as the University of Minnesota encompasses broad responsibilities for development and commercialization of products and he has been responsible for establishing quality strategy and implementing effective quality systems at numerous startup firms, has demonstrated expertise in establishing testing, monitoring and control programs, in compliance with US and international regulations and standards.

 

Mr. Tlachac has extensive compliance and regulatory experience, establishing effective compliance audit programs, leading numerous pre-approval inspections in US and Canada, and played a key role in seven New Drug Applications, and numerous IND, PMA, and 510K applications.

 

He has provided effective counsel on numerous development projects, including product transfers and outsourcing of contract manufacturing and testing for active pharmaceutical ingredients, finished drugs and medical devices.  Those responsibilities also included developing and directing quality programs, strategies and systems for preclinical and safety studies as well as human clinical trials at various regulatory stages.  He has taken the leadership or has been the author of numerous CMC sections, and Drug Master Files, and played a significant role in the approval of 7 New Drug Applications.

 

 

Tlachac has considerable practical experience with contract research organizations as well as other contract service providers, major clinical study sites and investigators to successfully complete various phases of bio-pharmaceutical research and development.  He has directed or overseen compliance audits of CROs, CMOs, CRLs for compliance with ISO, Quality System Regulations, GMPs, GCPs, and GLPs and is facile with all standards, guidelines and regulations.

 

 

Tlachac has been involved in technology development and licensing, technology transfer, and has provided strategy and authored numerous long term Supply Agreements and Quality Agreements to support successful development and manufacturing relationships.

 

 

Randall Tlachac is currently serving on the Parenteral Drug Association BioAB EMEA MAb Guidelines Task Force.