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COURTLAND IMEL

COURTLAND IMEL

Consultant to FDA Regulated Industries

location_on Dallas/Fort Worth Area

Chairman of the RAQA Committee at bionorthTEXAS

CEO at Ceutical Laboratories, Inc.

Awards Earned:

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Level: LEVEL 01 (12mo pts: 10 pts)

Rating: 5.00/5 stars (6 ratings)

Lifetime points: 335 pts View details

Thought Leadership:

% performance based on average of all engagements

Selected: % of applied

50%

Recognized: Contributions valued by peers

12%

Peer Support: Percentile of active participants

41%

Profile

Summary

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.

Experience

Chairman of the RAQA Committee

bionorthTEXAS

June 2015 - Present

Developing the cross relationships between quality and regulatory professionals across the state.

CEO

Ceutical Laboratories, Inc.

June 2004 - Present

Facilitate customer requirements to ensure customer success through services provided by my company. These services include product development, product concept, verification, validation, quality systems implementation, regulatory compliance, regulatory submissions (510K, PMA, IND, NDA, ANDA, DMF), training, IT solutions, sales and marketing assistance. Our goal is the success of our client. Recent audits by FDA yielded no observations!

Skills

FDA 11
Analytical Chemistry
Regulatory Affairs
Regulatory Strategy
FDA Compliance
Regulatory Submissions
Protocol Writing
Cleaning Validation
Quality by Design
Methods Development
Ion Chromatography
XRF
ICP
ICP-OES
NIR
Product Assessment
Project Oversight
Food Quality
Environmental Microbiology
Bioanalytical Chemistry
Carbohydrate Chemistry
Regulatory Expertise
Quality Auditing
Management Review
Preventive Actions
Validations
Mass Spectrometry
Capillary Electrophoresis
Gas Chromatography
IR spectroscopy
Titration
Extractions
pH meter
Spectrophotometry
Failure Modes
Fault Tree Analysis
510 K
PMA
IND
ANDA
Regulatory Documentation
GxP
GAMP
21 CFR Part 11
ISO 14971
QSR
ISO 13485
CAPA
Supplier Audits
Independent Verification & Validation

Industries

Activities