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COURTLAND IMEL
Consultant to FDA Regulated Industries at bionorthTEXAS
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COURTLAND IMEL
Consultant to FDA Regulated Industries at bionorthTEXAS
Joined 12/11/2017
Level: LEVEL 01 (12 mo pts: 0 pts)
Rating: 4.7273/5 stars (11 ratings)
Lifetime points: 806 pts
Senior Consultant with experience in product development, quality, validation, training, regulatory compliance, and regulatory submissions (IND, NDA, ANDA, 510K, PMA, and DMF) for pharmaceutical, medical device, nutraceutical, cosmetic, and vet products.
Started Ceutical Labs to provide the needed infrastructure that many companies lack, but require to manage projects and daily activities. We provide total outsourcing capabilities for R&D, the Quality Unit (Quality Control, Quality Assurance, Document Control, Regulatory Affairs), Training, Project Management, and Outsource Manufacturing to ensure success of the company. We have been very innovative in our approach and success.
Specialties: Regulatory compliance (FDA warning letters, consent decrees, 483 response, ISO13485, and ISO9000) and regulatory oversight, regulatory submissions (IND, NDA, ANDA, 510K, PMA, and DMF), quality systems management, document control, validation, analytical chemistry, microbiology, product development, consulting, training, and creative ideas for success. Introduction of new products or to complete family of products for revenue generation has been key.
Started Ceutical Labs to provide the needed infrastructure that many companies lack, but require to manage projects and daily activities. We provide total outsourcing capabilities for R&D, the Quality Unit (Quality Control, Quality Assurance, Document Control, Regulatory Affairs), Training, Project Management, and Outsource Manufacturing to ensure success of the company. We have been very innovative in our approach and success.
Specialties: Regulatory compliance (FDA warning letters, consent decrees, 483 response, ISO13485, and ISO9000) and regulatory oversight, regulatory submissions (IND, NDA, ANDA, 510K, PMA, and DMF), quality systems management, document control, validation, analytical chemistry, microbiology, product development, consulting, training, and creative ideas for success. Introduction of new products or to complete family of products for revenue generation has been key.
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