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: 733424 Pennsylvania, USA

Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions

Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…

ID: 732491 Washington, USA

Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices

Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…

ID: 731331 Illinois, USA

CGMP,Pharmaceutical Manufacturing and Operational Excellence

Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…

ID: 725448 Colorado, USA

Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance

In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…

ID: 723691 Florida, USA

Pharmaceutical Manufacturing, Research and Development, Education & Training

Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…

ID: 739165 Georgia, USA

Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia

40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…

ID: 723693 Florida, USA

Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation

As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…

ID: 735625 South Carolina, USA

Pharmaceutical and Fine Chemicals, Small and Large Scale Manufacturing

I earned my PhD at the Technical University (TU) of Karlsruhe, Germany in Organic Chemistry. I have knowledge and experience in the following realms: - Phospholipids - Pharmaceuticals (R&D, Manufacturing) - Vitamins. Highly motivated, results oriented professional with over 35…

ID: 733859 Arizona, USA

Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines

Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…

ID: 733372 New York, USA

Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing

Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…

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