Lyophilization Technology
Lyophilization Technology offers an extensive range of scientific services and technical support in freezing and freeze drying. Since its inception, the company has grown to provide a wide variety of services in diverse applications of the technology. These services encompass product design, formulation development, process engineering, and preparation of Phase I and II clinical supplies. Applying experience and expertise in providing services to the industry is coupled with interests in applied research and advancing the technology. These interests include the design, evaluation, and processing of product packaging and delivery systems. This combination of a commercial enterprise and interest in research offers a unique source of comprehensive expertise that spans bringing a new product to market to increasing the productivity of existing operations
SL Pharma Labs
SL Pharma Labs, Inc., is a well-established GMP-compliant CRO that provides a range of high quality customized services for CMC development. Its core competencies and capabilities include: pharmaceutical development/technology, clinical manufacture (phase 1 and phase 2) of parenteral and topical dosage forms, all aspects of analytical development & validation, microbiological development & validation, method transfers, quality control release and stability testing as per ICH. SL Pharma is qualified to perform all needed testing to support formulation development, process development, package development, release of batches and stability testing plus CMC documentation. SL Parma Labs, Inc is a FDA registered and inspected facility.
West Analytical Services
West Analytical Services provides specialized testing for drug administration systems, devices and packaging. West’s services include extractables and leachables, functionality, compendial and stability testing. Through a unique blend of experience, expertise and focus, the West team has a thorough understanding of pharmaceutical product development and the current regulatory environment. West’s wealth of knowledge and experience in laboratory testing and regulatory guidances helps customers mitigate the risks associated with package selection and keeps product development moving forward. The laboratory team works closely with clients to ensure that analytical testing meets appropriate methods, including those listed in the USP, Ph.Eur., ISO and other global agencies. West’s laboratories are FDA-registered and GMP-compliant
Whitehouse Analytical Labs
Whitehouse Analytical Labs is a full service chemistry based lab which is a GMP compliant, FDA regulated and inspected testing facility specializing in: container testing and packaging inspection; monograph testing and general chemistry; USP/EP gas testing; vacuum decay leak testing; package shipping testing; stability and storage programs, Instron method development and testing; and label adhesion studies.
American Glass Research
American Glass Research, a unit of AGR International Inc, is an independent research laboratory that has been supplying consulting services to users and manufacturers of pharmaceutical glassware for over 50 years. The areas of expertise include: Evaluation of flaw types; Fracture Analysis to determine the cause of failure; Performance Testing to determine the resistance to breakage; Computer Design Analysis; Filling Line Audits to identify areas of abuse; and Training Seminars covering fracture analysis and defect identification. We are qualified to perform a number of Glass Technology Services including: FTIR Analysis; SEM/EDX Analysis; Polariscopic Examination; Identification of Glass Types; Surface Contaminant Identification; and others. Our staff can assist with the design and manufacture of glassware, as well as, subsequent problems from breakage, handling damage, weathering of the glass surface, and labeling issues.