LDT Health Solutions, Inc.
Experience, Expertise, Unsurpassed Customer Service

Founded by Pharmacists to provide the highest quality consulting services nationwide all areas of Healthcare.

Our Consulting Services

As a leader in CSP compounding and medication safety, LDT can develop and present on a myriad of clinical and operational topics. These areas include but are not limited to:
  • 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
LDT can develop and present these topics live, by webinar, or as part of your organization’s staff development efforts.

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 health 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.
Since November of 2013 with the enactment of the Drug Quality & Security Act (DQSA) the Congress has established Outsourcing Facilities under Section 503B of the Food Drug & Cosmetics Act. These 503B providers are expanding the areas where compounded sterile preparations (CSPs) can reach the patients who need them. Compounding these CSPs for office use, and institutional prescribing is an expanding marketplace.
With our experience in construction, developing and running successful multi-state compounding facilities under both Board of Pharmacy and cGMP regulation, LDT can guide you through the selection process if your organization, health system, or health network is contemplating such a shift in your medication delivery model.
Our services include:
  • Development of your selection criteria
  • Conformation of your project’s feasibility through the use of LDT’s own r-ROI™ (realistic-ROI cost modeling) for your projects budgeting.
  • Formulation of your RFP
  • On-Site Compliance Visits (both initial and on-going)
  • On-going QA Visits and Audits
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.
This comprehensive strategy includes:
  • Clean Room Design & Construction Expertise
  • Policy & Procedure Review and Development
  • On-Going QA Visits and Audits
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.

LDT can lend its experience and expertise to access your organization’s compliance and regulatory readiness.

  •  CGMP (Current Good Manufacturing Practices / 21 CFR)
    •  503A & 503B (including all FDA regulatory guidance documents)
  • Pharmaceutical Compounding – Nonsterile Preparations <USP 795>
  • Pharmaceutical Compounding – Sterile Preparations <USP 797>
  • Handling of Hazardous drugs in healthcare settings <800>
  • DEA Regulation & Compliance
  • State Board of Pharmacy Inspection Readiness

LDT can assist in identifying areas for improvement and suggest creative and proven methods to maximize your staff’s capabilities.

The labor force of any organization, no matter how large or small, represents the largest investment of time, talent, and monies to any company. Inefficient use of this
single critical resource can lead to a downward budgetary spiral in any organization. LDT can assist in identifying areas for improvement and suggest creative and proven methods to maximize your staff’s capabilities.

Whether the answers lie with staff training & development, addition of technologies & software, or the launch of best demonstrated practices in key areas, LDT can develop a tailored program to fit your company’s needs and goals.

LDT can assist in this on-going activity by analyzing your P&P collection to look for procedural gaps, regulatory inconsistencies, and to assure that your organization is operating using the latest best demonstrated practices to strive for peak efficiency.

The Policy and Procedure Manual of any company is the backbone of it quality mosaic. A proper P&P library serves as its training & teaching tools, its sales tools, as well as the company’s greatest asset in developing and maintaining the company’s quality commitment to its customers. The idea that the P&P library of any organization is a static thing is absurd and, in a health care setting, dangerous. The on-going review of your company’s standards should be a core activity that reflects your organization’s commitment to its employees as well as the community it serves.

LDT can assist in this on-going activity by analyzing your P&P collection to look for procedural gaps, regulatory inconsistencies, and to assure that your organization is operating using the latest best demonstrated practices to strive for peak efficiency.

Through the process of reviewing your organization’s activities and focusing on the possible points of “critical failure” LDT can develop systems which may minimize or eliminate these “failure points” and enhance the overall quality of your products or services.

Being sure that key operations within your company are performed with the same high standards each and every time is a concern of all executives. This is the basis of a good quality management program within any organization. This is especially difficult to manage when key tasks are manual ones.
LDT has particular expertise in development of solid controlled process methodologies. Through the process of reviewing your organization’s activities and focusing on the possible points of “critical failure” LDT can develop systems which may minimize or eliminate these “failure points” and enhance the overall quality of your products or services.
By using this controlled process mentality, we can assist in developing higher standards of practice and greater organizational efficiencies. These higher levels of practice need not add laborious steps for staff or exorbitant cost for the organization. Our reviews and assessments can focus some of the following areas:
  • Compounding methodologies and documents
  • Manufacturing processes and documents
  • Labeling & Packaging processes
  • Label standards
  • TALL-man lettering & recommendations
  • Bar-coding recommendations (“1-d” and “2-d” formats)

Once an organization has taken stock and identified key areas for improvement or gaps in current practice, the task of developing a “road-map” to get there is sometimes daunting.

Once an organization has taken stock and identified key areas for improvement or gaps in current practice, the task of developing a “road-map” to get there is sometimes daunting. Even when the course is clear, development of a solid plan while considering and balancing all the needs of the organization can also be problematic.

Let LDT bring its experience to assist you in creating a custom project plan that can be sensitive to all of these individual needs while maintaining a laser focus on the success of the project at hand. We have decades of successfully delivering time-sensitive projects, on-time and on budget.

LDT has a broad experience in the formulation of custom POCs to address State Board, FDA form 483 deficiencies, and responses to FDA Waring Letters and other agency correspondence.

At times no matter how well an organization plans, develops, or trains it people, or how focused it is on maintaining the best and most up-to-date controlled processes, the need for an intensive corrective action is necessary. In these cases, administrative oversight and approval is needed to assure that the corrective action plan meets all the needs of the organization and perhaps satisfies the regulatory oversight in place.

LDT has a broad experience in the formulation of custom POCs to address State Board, FDA form 483 deficiencies, and responses to FDA Waring Letters and other agency correspondence. LDT maintains the largest private database of FDA public documents relating to compounding in the nation. We can mine this data to provide trending and focused reporting to assist your organization in formulating the most efficient and coherent remediation plans.

At critical times like these let LDT partner with your organization to bring it expertise in regulatory and administrative procedures to assist you in this process. We specialize in developing time-critical action plans to address these types of situations. Let LDT join your legal, administrative, and operational team to assure that your response plan is measured, appropriate, and timely.

Investing and developing good people is an essential piece of the “quality mosaic” which is the foundation of a solid quality system in any health care setting. Gearing your staff education and development pathways to your specific health care business need not be complicated or expensive.
At LDT we can combine audio, video, and PC based learning modules into the foundation of your “quality mosaic”. Our quality philosophy begins with competency-based learning; from there you can build a solid team. When your staff takes ownership of the quality culture that you have created, they become the most reliable teachers of new employees. This is LDT’s staff development goal.
At LDT we can access and evaluate your current system and develop a custom-tailored solution that fits your needs. Whether it is a fully custom-tailored training program or a combination of existing materials LDT can develop a solution that is correct for you and your organization.

Nationally recognized experts in Automated Compounding Technologies having written and spoken on these and other health care and technology topics.
  • Automated Compounding Devices
  • Implementation & Strategies
  • Robotics Integration
  • Telepharmacy Verification Systems
  • Remote Cleanroom Environmental monitoring
  • Bar coding strategies
  • For Inventory accountability & tracking
  • Label design & control