Business Consulting Cleanroom Design & Buildout Fractional Leadership Product Development Environmental Monitoring Program Design Operations Personnel Training Protocol Design SOP Customization Accreditation Adverse Drug Event Reporting Gap Analysis Expert Witness Licensing & Registration Probation Monitoring Recalls Regulatory Response Quality System Overhaul Supplier Audit
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Compounding

Business

Consulting

The pharmaceutical compounding industry is dynamic with respect to product demands and the ever-changing regulatory landscape. 503A and 503B compounding organizations that utilize experts to plan and execute a new venture or grow an existing business are often more successful than their DIY counterparts. Pharmacies and outsourcing facilities that choose Restore Health Consulting LLC will get to market faster with better outcomes with our comprehensive business planning services.

 

The following bundled business services are provided exclusively to our BUILD & GROW clients

 

  • We provide a presentation identifying current general market trends (e.g., market research sampling of what’s selling in the marketplace, who’s doing what, regulatory considerations, etc.). 503A trends differ from 503B trends due to the distinct operations and regulatory framework governing each entity. As the pharmaceutical compounding industry is dynamic, the insights change routinely.

  • We help clients strategize which therapeutic area(s) and/or process(es) to focus their business on based off:

    -business objectives & priorities

    -SWOT analysis

    -resources

    -operational capacity & capability

    -business relationships

    -geographical targets

    -market aim

  • We provide a report or presentation outlining the general facility, personnel, supplies, equipment, & resources required to execute the 503A or 503B business strategy.

  • We provide a spreadsheet answering how long it will take to build or grow the business, how much it will cost, how much it will gain, and month over month growth rate. Projections are based on assumptions from the market assessment, business strategy, and impact and implementation summary.

 

Ready to get started?

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Cleanroom Facility Design and Renovations

Cleanrooms must be built or renovated correctly in order to provide safe, high-quality compounded preparations to patients. Hospitals and 503A pharmacies need to meet USP <795>, USP <797> and USP <800> standards while 503B outsourcing facilities must meet CGMP and follow 21 CFR 211. Since this type of project is expensive and can take many months to complete, you want to make sure it gets done right the first time. Let us take the guess work out of designing a compliant cleanroom facility that will be engineered well to produce quality compounds and reduce the potential for contamination.

 

What We’ll Do

 

  • Develop the Cleanroom Layout & Specs

  • Select the Builder

  • Manage the Cleanroom Build-Out Project

  • Identify Appropriate Equipment & Materials

  • Design the Workflow & Customize Compounding SOPs

  • Train Key Personnel on Compounding

  • Prepare for & Conduct an Inspection Readiness Audit

 
 

Ready to get started?

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Fractional Leadership

A fractional leader provides expertise to a business on an outsourced, part-time, or project basis to execute an objective. With this service, you get an experienced leader without the cost of a full-time executive and with more time to focus on what you do best.

 

The approach is a good fit if:

  • It’s too soon for full-time - the business is new or cannot financially justify the cost of another full-time executive

  • You need a coach or mentor with a certain skillset or fresh perspective

  • A key employee just left or was terminated and you need someone now

  • You are not sure what you need

  • The company is experiencing significant growth or looking to raise money

 

What We Do

Restore offers leadership solutions for compounding organizations going through dynamic and challenging growth phases including:

  • Business Management Oversight

  • Operational Efficiency Guidance

  • Due Diligence Audits and Corrective Actions

Our team has been leading hospital, pharmacy, and 503B outsourcing facilities for over 20 years. Our model allows for customizable solutions to be crated around your objectives - from short-term interim roles to annual fractional positions.

 

Ready to get started?

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Product Development

Whether you’re in the end-stage development of an exclusive compound or trying to break into a new healthcare specialty, you need the right business strategy to be successful. We help pharmacy compounders and outsourcing facilities assess the financial, operational, regulatory and clinical factors of pharmaceutical compound development. We also define opportunities, targets, and obstacles of your specific compounds to maximize your market share of your unique preparation offerings. Let us help increase your revenue potential today!

 

We can help you with

Marketing plans, product development, business planning, market research, content creation, mergers and acquisitions, and more!

 

Ready to get started?

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Environmental Monitoring Program Design

What is the current environmental status of your organization’s cleanroom where sterile compounding takes place? When was the last time the air or surfaces of critical areas were tested for the presence of contaminants? How were the site locations or number of test sites decided upon in the first place? Since the purpose of an environmental monitoring program is to demonstrate that a facility performs within control and is protecting the compound, it is important to properly design, implement, and perform environmental monitoring at a practice site. Let us design or update your EM program so you can demonstrate that the facility performs within control, protects individuals, the environment, the process, and the product.

 

What We’ll Do

 

  • Assess the Facility Design and Operations

  • Provide a Written Justification for Sample Site Locations, Frequencies, and Limits

  • Devise a Sampling Map

  • Customize SOPs for the EM Program, Air Sampling Equipment, Sampling Methods and Reading Results

 
 

Ready to get started?

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Operational Efficiencies

Does your business operate efficiently with minimal waste? Our experts can assess your operations, streamline processes, and identify cost saving opportunities so that you work smarter not harder to produce more compounds in less time.

 
 

What We’ll Do

  • Audit the current compounding operations - process(es), equipment, personnel, outputs, costs, etc..

  • Identify opportunities to improve efficiency and effectiveness of the organization's operations.

  • Provide an advisory summary report.

 
 

Ready to get started?

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Personnel Training

Our consultants have extensive USP <797>, USP <795>, USP <800>, and cGMP - 21 CFR 211 experience. We provide on-site or remote personnel training so compounding staff may be trained to their specific procedures on their own equipment. Topics are customized to your needs. Schedule your next training today!

 

We’ll Teach You

Gowning, Hand Hygiene, Cleanroom Behavior, Aseptic Technique, Cleanroom Contamination Control, and/or Customized Topics

 

Ready to get started?

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Protocol Design

503B outsourcing facilities, hospitals, and 503A pharmacies engaged in non-sterile or sterile compounding need to follow a detailed master formula to satisfy various regulatory and accrediting bodies. It is not enough to purchase and adopt cookie-cutter media fill kits or vague master formula templates. Your protocols must be detailed and applicable to your unique facility operations and regulatory requirements. Let us customize a master formula template, media fill, process validation, and any other documentation so that you can attain or maintain compliance with state Boards of Pharmacy, FDA, DEA, and if applicable USP <797>, USP <795>, USP <800> as well as PCAB or NABP accreditation standards.

 

What We’ll Do

Review Relevant Operations, Facility and Protocols, then Customize and Finalize the New Protocols

 

Ready to get started?

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SOP Customization

Pharmacies, hospitals, and 503B outsourcing facilities engaged in non-sterile or sterile compounding need to follow the appropriate written SOP’s to satisfy various regulatory and accrediting bodies. It is not enough to purchase and adopt cookie-cutter compounding SOP’s. Your procedures must be detailed and applicable to your unique facility operations and regulatory requirements. Let us customize your standard operating procedures so that you can attain or maintain compliance with state Boards of Pharmacy, FDA, DEA, and if applicable USP <797>, USP <795>, USP <800> as well as PCAB or NABP accreditation standards.

 
 

Ready to get started?

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Accreditation

Do you want to achieve pharmaceutical accreditation status but do not know where to start? We help facilities receive PCAB, NABP, or URAC accreditation. Our compounding consultants have trained at ACHC to be either surveyors or certified PCAB consultants. We conduct accreditation inspection readiness audits and prepare your facility to meet the standards.

 

Our Comprehensive Approach

  1. Develop, Implement, and Manage the Accreditation Project Plan for ACHC, URAC or NABP.

  2. Provide Policies and Procedure Templates that are Compatible with the Accreditation standards.

  3. Develop and Implement the Emergency Plan, Quality Management Program, Patient Management Program, Operations, and Staff Training.

  4. Coordinate Communications With the Accreditation Organizations.

  5. Train Staff on Accreditation Process and Standards.

  6. Develop Corrective Action Plans Based on Identified Deficiencies and Ongoing Internal Monitoring Trends.

 

Ready to get started?

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Adverse Drug Event Reporting

503As and 503Bs alike must have written procedures for the surveillance, receipt, evaluation and reporting of adverse drug events of pharmaceutical compounds to FDA and associated Boards of Pharmacy. A common mistake made by compounders is waiting too long to report an adverse drug event or not understanding what is classified as an adverse drug event. Some companies are tempted to wait until they have completed the investigation before reporting the occurrence.

 

Why Choose Us?

Our consultants have extensive experience in handling and reporting adverse events in a proper and timely manner to mitigate unnecessary regulatory backlash. We excel at assisting in report writing, investigating the event, and creating an action plan to prevent similar future events.

Your report must be submitted quickly, don’t wait too long to contact the right team to get you through this situation.

 

Our Approach

  1. Event Discovery

  2. Adverse Drug Event Report

  3. Investigation Support

  4. CAPA Plan

  5. Remediation Implementation

 

Ready to get started?

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Gap Analysis - Compliance Reviews, Audit Readiness, & Due Diligence

Is your compounding operation cGMP, FDA, DEA, Board of Pharmacy, USP, PCAB, or NABP compliant? Ready for your next regulatory or accreditation audit? Need to perform regulatory due diligence to assess the feasibility or market value of a merger or acquisition? Our experts are compounding veterans, having spent their careers in 503A, 503B, and pharmaceutical manufacturing settings. We conduct comprehensive reviews, mock audits, and gap analyses to assess compliance with the applicable pharmacy or outsourcing regulations and accrediting bodies. We outline where the gaps are and if you like, we’ll fix them, too.

 
 

What We’ll Do

1. Audit - Conduct a Compliance Audit
2. Report - Provide a Review of Findings Report
3. Fix - Remediate the Issues

 
 

Ready to get started?

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Expert Witness

Restore Health Consulting provides litigation support services in matters of 503A pharmacy and 503B outsourcing facility compounding laws and regulations. We provide expert witness depositions, testimony, evidence review and detailed reports specific to the issue. We also provide pharmacy probation monitoring services and assess compliance with probation agreements at the required frequency. If your compounding operation has been hit with legal issues, our expert witnesses and probationary consultants can help.

 

Our Holistic Approach

 

  • Evidence Review

  • Gap Analysis Audit

  • CAPA Planning

  • Remediation Implementation

  • Compliance Reassessment

  • Current Compliance Report

  • Expert Witness Testimony

 
 

Ready to get started?

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Multi-State Licensing & FDA Registration

Pharmacies and outsourcing facilities seeking licensure in multiple states will face unique licensing requirements in each state they serve. Some states for example require a pharmacist-in-charge who is actively licensed in that state. Others require the facility to obtain certain accreditations. The FDA requires 503B outsourcers to maintain registration with the Agency. Pharmacy and 503B licenses typically expire annually or biennially. Entities that hold multiple licenses will have to carefully track when renewals must be filed. Let us help you obtain and manage your licenses and registrations so you can focus on what you do best!

 
 

Ready to get started?

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503A Compounding Pharmacy Probationary Monitoring Consultant

Probation Monitoring

503A pharmacies and 503B outsourcing facilities facing disciplinary action may be placed on probation with the Board of Pharmacy. In this case, the compounding firm may be required to obtain board-approved consultant probation monitoring for the duration of the probation term.

If your compounding pharmacy, hospital, or 503B outsourcing facility has been placed on probation, our probationary consulting service can help fulfill the terms and conditions of the settlement or judgement. We provide pharmacy probation monitoring services and assess compliance with probation agreements at the required frequency.

 

Our Holistic Approach

 

  • Gap Analysis Audit

  • CAPA Planning

  • Remediation Implementation

  • Education

  • Compliance Report

 
 

Ready to get started?

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Recalls - Compounded Drugs

Whether a recall is voluntary or requested by a regulator, 503As and 503Bs must have written procedures to initiate, trace and report recalls of pharmaceutical compounds to FDA and associated Boards of Pharmacy.

 

Our consultants have experience in handling and reporting compounded drug recalls in a simplified and timely manner to mitigate patient harm and regulatory backlash.

  • We partner with your leadership, legal, and communications teams to develop a comprehensive strategy to get you back on the market.

  • We excel at initiating the recall, investigating the event, and creating an action plan to prevent similar future events.

  • We can also conduct mock recalls to assess your readiness to execute an actual recall or perform a gap analysis as a proactive recall prevention strategy.

Your recall must be initiated and reported quickly and accurately, don’t wait too long to contact the right team to get you through this unfortunate situation.

 

Our Approach

  1. Event Discovery

  2. Recall Initiation and Execution

  3. Investigation Support

  4. CAPA Plan

  5. Remediation Implementation

 

Ready to get started?

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Regulatory Response

Board of Pharmacy | FDA | 483 | Warning | Accusation | Plan of Correction

If your organization has been hit with a FDA Form 483, warning letter, or Board of Pharmacy accusation or plan of correction mandate, you don’t have much time to respond and correct the deficiencies. What you need is a team of experts that have seen it all and can help you respond quickly to a regulator with cost-effective solutions that adequately address the problems. Restore Health Consulting can support you through this difficult time so you can put this in the past quickly and get on with making quality compounded preparations.

 

Ready to get started?

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Compounding Pharmacy Quality Assurance Consultant

Quality System Overhaul

- Investigate the failures or regulatory citation
- Provide a root cause analysis report
- Create a CAPA plan
- Fix and prevent the deficiencies

 
 

Ready to get started?

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Critical Supplier Audit

The FDA is cracking down on API suppliers. Almost daily, pharmaceutical firms broadcast recall alerts for their FDA approved drug products. The materials you use in your compounding operation can make or break you. Hospitals and pharmacies may not have the time or be well-versed in GMP to conduct an adequate audit of a compounding material supplier. 503B outsourcing facilities may also prefer to sub this work out to a competent GMP auditor so they can focus on mass production. Our consultants have extensive audit and GMP experience. Don’t take time away from your operation. Let us take the guess work out of auditing your critical compounding material suppliers.

 

What We’ll Do

  • Conduct a Compliance Audit: Assess the Facility, Equipment, Training and Documentation, Process Controls, Finished Product Testing, and Quality Assurance Program

  • Provide a Findings Report

  • Recommend Remediations

 

Ready to get started?

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