mikart.com
Clinical Trial Manufacturing | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/mikart-pharmaceutical-manufacturing/clinical-trial-supplies
Controlled Substances (CII – CV). Mikart offers a comprehensive range of clinical supply services for solid oral dose and non-sterile liquid products. We can manufacture, package, label and distribute your clinical trial materials for later phase (III and IV), multi center, open-label and double-blind randomized studies. Our services are cGMP, GCP and GLP compliant and include established procedures in accordance with the CFRs and ICH Guidelines. Custom Secondary Packaging and Patient Supply Kits.
mikart.com
Analytical Method Development | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/pharmaceutical-development/analytical-method-development
Site / Tech Transfers. Throughout the development process, the R&D Analytical Laboratory is involved in assessing the physical and chemical characteristics of both the drug substance and the candidate drug product formulations. Mikart’s analytical team works hand in hand with the Formulators throughout the Pre-Formulation and Development stages to assure that the critical quality attributes of the API and product meet requirements. Analytical Method Development and Validation. Verification of USP Methods.
mikart.com
Commercial Manufacturing | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/mikart-pharmaceutical-manufacturing
Controlled Substances (CII – CV). Ready to move your product. Our capabilities include fluid bed granulating, high shear granulating, roller compacting, film coating and other advanced manufacturing technologies to ensure your product is made according to the highest quality standards. Whether you have a requirement for clinical trial materials, physician samples or commercial product, Mikart offers a variety of solutions to fit your needs. Mikart, Inc. Atlanta Georgia, USA 1-888-4MIKART.
mikart.com
Capsules Manufacturing | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/mikart-pharmaceutical-manufacturing/capsules
Controlled Substances (CII – CV). Whether you have a requirement for clinical trial materials or commercial product, Mikart offers a variety of capsule options to fit your needs. We can take your product from formulation development through full-scale commercial production. Our advanced manufacturing technologies ensure your product is made according to the highest quality standards. We offer a wide variety of processing choices including Fluid Bed Granulating, Fluid Bed Drying, and Wurster coating.
mikart.com
Pharmaceutical Development | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/pharmaceutical-development
Site / Tech Transfers. You design the molecule. We’ll deliver the finished product. We offer a range of services, customized to fit your specific project needs. Our Pharmaceutical Formulations group specializes in developing robust product formulas which can be transferred to commercial level manufacturing. Our processing capabilities include:. High Shear Wet Granulation. Fluid Bed Top Spray. Mikart, Inc. Atlanta Georgia, USA 1-888-4MIKART.
mikart.com
Liquid Dosage Manufacturing | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/mikart-pharmaceutical-manufacturing/liquids
Controlled Substances (CII – CV). Whether you have a requirement for clinical trial materials, physician samples or commercial product, Mikart offers a variety of non-sterile liquid options to fit your needs. We can take your product from formulation development through full-scale commercial production. All of our manufacturing and packaging suites have separate air handling and filtration systems to ensure complete quality control during all phases of production. Controlled Substances (CII – CV).
mikart.com
Blister Packaging | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/packaging/blistercarded-blisters
Controlled Substances (CII – CV). Whether you have a need for physician sample packs, patient compliance packaging, clinical trial materials or hospital unit dose packs, Mikart offers a wide range of blister options to fit your packaging needs. We can blister pack tablets, 2-piece hard-gel and soft-gel capsules. Our state-of-the-art blister packaging equipment manufactures both thermoformed and cold-formed blisters. Mikart, Inc. Atlanta Georgia, USA 1-888-4MIKART.
mikart.com
Product Application Support | Mikart Pharmaceuticals | Mikart
http://www.mikart.com/pharmaceutical-development/product-application-support
Site / Tech Transfers. Our experienced team of regulatory professionals dedicated to new projects will prepare and submit your project’s application on your behalf, or provide a package to you that is submission-ready. Regulatory staff are integrated into the R&D group to assure that the regulatory aspects are addressed throughout the product and analytical development stages. Application Compilation and Submission in e-CTD Format. Regulatory Support for Interactions with Governing Agencies.
nexgenpharma.com
Industrial Links - Nexgen Pharma - Manufacturing Rx and OTC Drugs and Dietary Supplements
http://www.nexgenpharma.com/links.html
Middot; Specialty Pharma Association. Middot; Generic Pharmaceutical Association. Middot; Center for Disease Control. Middot; Department of Health and Human Services. Middot; Food and Drug Administration. Middot; Center for Drug Evaluation and Research. Middot; Office of Generic Drugs. Middot; National Institutes of Health. Middot; U.S. Pharmacopeia. Middot; Natural Products Association. Middot; Council For Responsible Nutrition. Middot; FDA/CFSAN - Dietary Supplements. Middot; America Botanical Council.
