Ceutical Labs
Provider of laboratory testing, regulatory consulting, formulation and process development, and contract manufacturing for pharmaceuticals, medical devices, nutraceuticals, cosmetics and veterinary products. Services include analytical and microbiology testing, stability studies, GMP manufacturing (sterile and non-sterile), device prototyping and assembly, sterilization coordination and validation, regulatory submission support, quality systems implementation and clinical supply support.
Industries
Nr. of Employees
medium (51-250)
Ceutical Labs
1500 Lakeside Parkway, Suite 100A, Flower Mound, Texas 75028
Products
Medical Device Manufacturing
Manufacture, assembly, testing, packaging, sterilization, and shipping of medical devices for various medical markets.
Laboratory Testing Services
Analytical chemistry, microbiology, physical, and quality testing for pharmaceuticals, medical devices, nutraceuticals, and cosmetics.
Product Development and Formulation
Development and scale-up of pharmaceutical, nutraceutical, cosmetic, and medical device products from concept to manufacturing.
Regulatory Compliance and Submissions
Support for FDA and global regulatory submissions, quality system implementation, and compliance management.
Quality Management Systems Consulting
Development and integration of quality management systems compliant with FDA and ISO standards for regulated industries.
Online Technology and Marketing Services
Web design, online marketing, e-commerce, and digital strategy services tailored for regulated product markets.
Medical Device Manufacturing
Manufacture, assembly, testing, packaging, sterilization, and shipping of medical devices for various medical markets.
Laboratory Testing Services
Analytical chemistry, microbiology, physical, and quality testing for pharmaceuticals, medical devices, nutraceuticals, and cosmetics.
Product Development and Formulation
Development and scale-up of pharmaceutical, nutraceutical, cosmetic, and medical device products from concept to manufacturing.
Regulatory Compliance and Submissions
Support for FDA and global regulatory submissions, quality system implementation, and compliance management.
Quality Management Systems Consulting
Development and integration of quality management systems compliant with FDA and ISO standards for regulated industries.
Online Technology and Marketing Services
Web design, online marketing, e-commerce, and digital strategy services tailored for regulated product markets.
Services
Testing services for raw materials, in-process samples and finished products, including stability, sterility and post-sterilization residual analyses.
End-to-end regulatory strategy, preparation and management of filings and agency interactions for drug and device programs, including electronic submissions.
Formulation design for oral, topical and other dosage forms and engineering support to transfer laboratory recipes to manufacturing scale.
Contract production of oral solids/liquids, topicals and sterile parenterals, including specialized formats such as lyophilized products and blow-fill-seal.
Prototype fabrication, component sourcing, assembly, testing, sterilization coordination and packaging for medical and veterinary devices.
Packaging selection and validation, transit testing and validated packaging equipment to ensure product integrity during distribution.
Testing services for raw materials, in-process samples and finished products, including stability, sterility and post-sterilization residual analyses.
End-to-end regulatory strategy, preparation and management of filings and agency interactions for drug and device programs, including electronic submissions.
Formulation design for oral, topical and other dosage forms and engineering support to transfer laboratory recipes to manufacturing scale.
Contract production of oral solids/liquids, topicals and sterile parenterals, including specialized formats such as lyophilized products and blow-fill-seal.
Prototype fabrication, component sourcing, assembly, testing, sterilization coordination and packaging for medical and veterinary devices.
Packaging selection and validation, transit testing and validated packaging equipment to ensure product integrity during distribution.
Expertise Areas
- Regulatory compliance and submission strategy for drugs and devices
- GMP manufacturing for sterile and non-sterile pharmaceutical products
- Formulation development and process scale-up with PAT implementation
- Analytical chemistry and microbiology testing
Key Technologies
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Atomic absorption spectroscopy
- Titration and wet-chemistry assays
News & Updates
Curated links and breaking news relevant to pharmaceutical, nutraceutical, cosmetic and medical device industries, including regulatory guidance and FDA items.
Curated links and breaking news relevant to pharmaceutical, nutraceutical, cosmetic and medical device industries, including regulatory guidance and FDA items.