Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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ID: 726036 Minnesota, USA

Medical Device Research and Development

Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…

ID: 726001 Netherlands

Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market

She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked…

ID: 725331 California, USA

Medical Device Regulatory Submissions

She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…

ID: 723723 North Carolina, USA

Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification

Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. He offers full…

ID: 723204 Illinois, USA

Biomedical Engineering; Medical Devices

IP Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home…

ID: 722568 Delaware, USA

Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms

As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…

ID: 107649 Oklahoma, USA

Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness

Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…

ID: 108105 South Africa

Biomedical Device Engineering

BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…

ID: 713381 Minnesota, USA

Medical Technology

A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…

ID: 107595 Illinois, USA

Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs

Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…

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