• Regulatory and other statutory compliance strategies, including the DQSA
• FDA activity in and around compounding pharmacies, prescribers & institutional providers (including hospitals)
• Automated Compounding Devices, Technologies & Techniques
• Compounding Under USP <795> & <797>
• Regional compounding of CSPs for your healthcare organization [503B model]
• Medication Safety & Quality Improvement topics
• Medication Quality Management & Policy Development
• Improving workflow, operational efficiencies, & policy compliance in the cleanroom
• Procurement strategies to assist in drug shortage situations
• Formulary management to efficiently procure CSPs
• Hazardous Drug compounding & Regulatory compliance - <USP 800> (OSHA & NIOSH topics)
• Evaluation of drug stability data & determinations of BUD of CSP formulations
• Personnel training programs for cleanroom operations
• Cleanroom design & building basics

Whether your business depends upon sterile or non-sterile pharmacy compounding or both, LDT’s pharmacists and certified technicians have a wealth of clinical and technical expertise in both cGMP and Pharmacy compounding. The delivery of compounded sterile preparations (CSPs) in the current heath care delivery model requires both technical resources and the employee training to prepare and deliver these CSPs safely. At LDT our team has over 40 years of compounding, outsourcing, and formulation experience.

We can analyze your process for regulatory and practice gaps. We can develop action plans for correction of these gaps, or analyze your operation for improvements or efficiencies to make your program better. Our experts can develop solutions that center upon the “controlled process” concept of using best-in-class” equipment and processes, in a defined and controlled way, consistently each and every time, and to document this process universally to satisfy any regulatory and oversight body.

LDT has developed compounding methodologies and accompanying documents for all types of pharmacy products including, Cardioplegia, Dialysate solutions (CVVH & CRRT), Total Parenteral Solutions (TPN), small volume preparations (SVPs) and Large volume parenterals (LVPs). Let us assist you in developing a consistent, solid library of compounding documents to reduce the possibility of errors and raise your level of quality in the mixing process.

LDT can assist you in the expansion or re-model of your current pharmacy space, or in a total redesign of your clean room complex. No project is too large or small; each complex is designed with your organization’s specific needs and demands in mind. All our projects use the "Pharmacist’s Eye" to work flow and efficient movement of product both in and out of the rooms. We specialize in design with careful attention to local regulation, and USP 795 & 797 considerations.

We can work with your organization’s contractors, architects, and builders to smoothly and efficiently get your complex build, validated, certified, and running. We also specialize in transition planning to assure that your critical functions are uninterrupted during any remodeling or construction. LDT has over ten years of experience in soft wall, hard wall, modular, and mobile clean room applications, please contact us for a consultation.

The provision of contracted compounding pharmacy services from off-site providers is a growing model in healthcare. Beginning in the early 1990’s hospitals have moved high volume, fixed formulations to contract compounders (outsourcing providers) rather than compound these preparations themselves. LDT can assist at several junctures in this service paradigm.

LDT can develop as part of your overall 503B outsourcing strategy, a comprehensive plan to accommodate the remaining compounding demands of your organization once you have moved your fixed formulations off-site. This type of strategy can reduce your organization’s overall expense in complying with Federal, State, and Local regulatory burdens, while still maintaining your organization’s ability to compound on site.

Finally, if you are part of a larger organization or perhaps have excess capacity in your compounding suite, LDT has unique technologies and procedures to aid you in "in-sourcing" your organization’s compounding needs. By centralizing your compounding your organization may benefit from reduced overhead costs, better control, and total autonomy over your processes. This would include the review of available automation to assist you in maximizing you "in-sourcing" capacity.

LDT has several business models for "In sourcing" that may apply inside or outside your organization. Please contact us for more specific information regarding this unique opportunity.