ABOUT US    
 
 

 

CONVENTUS BIOMEDICAL SOLUTIONS, INC.

is a privately-held consulting firm specializing in development solutions and global regulatory strategies and submissions for investigational medicinal products in early development stages through Phase 3. The Conventus team includes full-time expert personnel, and expert affiliates with deep expertise in multiple technical disciplines, who together comprise an integrated team with successful experience in a broad range of therapeutic areas and vaccine indications.

 

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STEVEN A. KRADJIAN, RAC
President and Principal Regulatory Consultant

Mr. Steven Kradjian is a veteran regulatory leader, drawing from his more than 25 years of experience in biopharmaceutical regulatory affairs and development, ranging from product candidate selection through late stage clinical development with cellular and gene therapies products, small molecules, recombinant proteins, monoclonal antibodies and combination products in a wide range of therapeutic areas, and investigational vaccines in populations at risk for infectious disease vaccines. He trained in regulatory affairs at Amgen while working on EPOGEN and other development programs, and later, as Executive Director of Regulatory and QA at Vical Inc., he gained experience as product development team leader in the Phase 2 and Phase 3 settings. As a consultant since 2004, he has served as regulatory strategy advisor to Sponsors in the U.S., Europe, and Asia, and has successfully filed 27 IND/CTAs and managed numerous formal and informal meetings with regulatory agencies. Mr. Kradjian earned a Bachelor's degree in Chemistry from Occidental College, with a thesis on reduced specificity of aminoacylation during protein synthesis in aging rats. He was Board certified in Regulatory Affairs in 2000 and completed the Executive Development program for Regulatory Professionals at the Kellogg School of Management.

   
 

ZENAIDA A. ORTEGA, MBA, CQE, CQA
Director of Quality Assurance

Zenaida Ortega is an accomplished Quality Professional with more than 25 years of proven management experience in pharmaceutical, biotechnology, and medical device industries with expertise in design, development, and implementation of Quality Systems. She has provided strong leadership and quality oversight of domestic and foreign contract manufacturers/service providers/suppliers for Phase I, Phase II, Phase III, and commercial products, ensuring compliance to regulatory requirements and Quality Agreements. She has effectively managed Quality Operations, including timely review and approval of master and batch production records, change control requests, raw material and product specifications, deviations, SOPs, formulation and test methods, investigations, CAPAs, stability, analytical and manufacturing data, complaints, protocols and reports, CMC submissions, final packaging, labeling, and distribution documentation. She is an experienced GMP trainer and has successfully managed and hosted client audits and regulatory inspections.

   
 

DAVID BERNAL, Pharm.D.
Director of Regulatory Affairs

David Bernal is a Director of Regulatory Affairs at Conventus Biomedical Solutions. He is an accomplished Regulatory Affairs Professional and Pharmacist. David has held multiple Regulatory Affairs and Medical Information positions throughout his career in the pharmaceutical industry. David has extensive experience in the advertising/promotion and labeling areas of regulatory affairs. He has successfully lead the launch of 3 products which includes a total of 5 indications. He has trained and mentored numerous people is this area and has also led the advertising/promotion and labeling group at a large bio-pharma company. Prior to a career in regulatory affairs, David worked as a Medical Information specialist in a pharma company. He also worked as a pain management pharmacist at the City of Hope National Medical Center and continues to do community pharmacy relief work.

   
 

PETRA PAVLICKOVA, Ph.D., RAC
Associate Director of Regulatory Affairs

Petra Pavlickova is Associate Director of Regulatory Affairs at Conventus Biomedical Solutions. She is an accomplished Scientist and Regulatory Affairs Professional. Petra has held multiple Regulatory Affairs positions in biotechnological companies developing and manufacturing in vitro diagnostic assays, biologics and medical devices. She has domestic and global regulatory affairs experience with commercial products and product candidates in development. Petra has successfully filed multiple INDs, original BLAs, amendments, supplements and annual reports for blood screening assays (biologics). She has an extensive experience with requesting and leading FDA meetings and responding to Information Requests. Petra has compiled and supported 510(k) and PMA submissions for IVDs and authored Technical Files and Design Dossiers for EU market distribution. In addition, Petra has been directly involved in FDA (CBER) inspections and was responsible for regulatory assessments and MDR/ Vigilance and BPDR reporting. Prior to her regulatory affairs career, Petra has worked in research organizations on the identification of potential small molecule drug candidates for treatment of neurodegenerative disorders and inhibition of cell proliferation.

   
 

KURT NORTON, MS
Regulatory Associate

Kurt Norton is a Regulatory Associate at Conventus Biomedical Solutions. He is an accomplished Scientist and Regulatory Affairs Professional. Kurt has held multiple Scientist positions in biotechnological companies developing and manufacturing in vitro diagnostic assays, medical devices and biologics. Kurt has regulatory affairs experience with product candidates in development and commercial products. He has experience with IND, NDA and DMF submissions. Kurt has prepared summary reports, addressed information requests, and amended product inserts and SOPs. He has completed a product name change for Health Canada. Prior to his regulatory affairs career, Kurt has extensive experience as a Scientist in research organizations utilizing monoclonal antibody or nucleic acid technology to detect cancer cells, viruses, bacteria and other molecules of interest in the human body. He has served as a peer trainer and travelled to provide training to personnel performing clinical trials.

   
 

LISA KRADJIAN
Writer and Administrator

Lisa is a professional writer and editor with credits in multiple local and national publications including the Los Angeles Times and the San Diego Union Tribune and NPR/KPBS Public Radio. Her work includes writing and editing annual reports, grant proposals, speeches, company newsletters, direct mail campaigns, articles, and web and social media content, for both corporations and nonprofit organizations across various industries. She also has administrative management experience at companies including MetLife Insurance, The Music Center Inc. of Los Angeles County, and the Museum of Contemporary Art and has served on numerous boards. Lisa is a graduate of Stanford University (BA English with Honors, 1992).


 
 
 
 
 
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