Monarch's® vast experience in analytical method development & validation allows us to support your product development objectives through all stages of the product life cycle. Our expertise lies in a variety of platforms including HPLC, AA, GC and many others. Once your method is developed, Monarch® can then validate the method according to FDA, USP, EP or ICH guidelines to determine its suitability for its intended use.
Monarch® offers analytical support for formulation development, process and cleaning validation support, reference standard characterization with reporting, full excipient testing and release, and a full range of microbiological testing capabilities.
Monarch® has a wide array of in-house stability study capabilities. Our comprehensive services include stability protocol design, program management, storage and testing, and data trending/shelf life assessment in qualified stability rooms/chambers.
Monarch® uses a variety of preformulation characterization approaches to pinpoint the best processes and excipients needed to accomplish your formulation goal. Our formula development expertise includes powders, tablets, powder and granule filled hard gelatin capsules, ingestible and topical liquids, creams, lotions, salves and gels.
Monarch® develops hundreds of tablet and capsule formulations under cGMP conditions. Tablet forms range from immediate-release generated by direct compression processes to sophisticated controlled release dosages with multiple functional coatings, fast-dispersible tablets, chewable tablets and water-dispersible effervescent tablets. Our capsule formulations use both powder and granule technologies in a number of capsule sizes ranging from size 3 to size 00 and in both vegan and non-vegan hard gelatin capsule shells.
Monarch's® formulation expertise in nano, micro and micelle technologies makes us industry leaders in the formulation and manufacture of liquid and semi-solid formulations. We offer expertise in developing clear solutions, emulsions, tinctures, gels, creams, toothpastes and lotions in both aqueous and organic bases.
Monarch® provides a variety of customizable packaging solutions including bottles, tubes, jars and canisters in numerous shapes, volumes and sizes and flexible packaging options from as small as a single-serving up to large bulk containers. Monarch can also package finished units into display cartons of various count configurations.
Monarch® offers comprehensive pharmaceutical serialization services in full compliance with the track and trace requirements of the Drug Supply Chain Security Act (DSCSA) of 2013. As such, Monarch assists our customers with increased transparency and visibility by helping to reduce theft, diversion and counterfeiting, increasing shipping accuracy and providing a more efficient process to quickly remove recalled or defective product.
Monarchs® Quality Systems operate under strict adherence to strict cGMP guidelines to ensure that your products contain exactly what you say they contain and are handled accordingly. Our uncompromising approach to quality is to pursue improvement in every aspect of the business, prevent problems before they occur and take a continuous-improvement mentality in examining systems and processes. At Monarch, we are committed to the safety and health of our employees and the protection of our environment. Our company culture is based on teamwork dedicated to prevention, compliance, and manufacturing excellence.
Monarch PCM, LLC
7333 Jack Newell Blvd. North, Suite 100
Fort Worth, TX 76118
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