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 CGMP Validation Services
Consultant Search Join Our Consulting Team
Regulations & Standards Checklists Education Sample SOPs and Diagrams White Papers
We solve problems to save your business time and money.
 

Business

Consulting

Today GMP manufacturing and compounding industries are dynamic with respect to product demands and the ever-changing regulatory landscapes. 503A & 503B compounders and personalized medicine manufacturers that utilize experts to plan and execute a new venture or grow an existing business are often more successful than their DIY counterparts. Pharmacies, outsourcing facilities, and specialty GMP manufacturers that choose Restore 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?

2022-10-04 12_06_28-.png
 

Cleanroom Facility Design and Renovations

Cleanrooms must be built or renovated correctly in order to provide safe, high-quality preparations to patients. Hospitals and pharmacies need to meet USP standards (e.g.; <795>, <797>, <800>) while 503B outsourcers, cell & gene labs, and drug manufacturers must meet CGMP and follow pertinent FDA guidance and CFRs. 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. We take the guesswork out of designing and building compliant cleanroom facilities—engineered to minimize contamination & support high-quality drug production.

 

What We’ll Do

 

  • Develop the Cleanroom Layout & Specs

  • Offer a Selection of Build-Out Teams

  • Support the Cleanroom Build-Out Project

  • Identify Appropriate Equipment & Materials

  • Design the Workflow & Customize SOPs

  • Train Key Personnel

  • Conduct an Inspection Readiness Audit

 
 

Avoid costly start-up mistakes

2022-10-04 12_06_28-.png
 

Get Executive-Level Expertise—Without the Full-Time Cost

Our fractional leadership service gives you access to seasoned experts on a part-time or project basis—so you get high-impact results without the overhead of a full-time executive. Whether you're launching a new program, fixing a compliance gap, or scaling operations, we bring the leadership to move your objectives forward.

Who could be on your team when you work with us? Former executives and quality leaders from QuVa, CAPS, Hims, Amazon, Amgen, Fujifilm, the FDA, Boards of Pharmacy, and more.

 

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

  • Quality Systems Overhaul

  • Due Diligence Audits and Corrective Actions

Our team has been leading compounding and GMP manufacturing facilities for over 20 years. Our model allows for customizable solutions to be created around your objectives - from short-term interim roles to annual fractional positions.

 

Plug in executive leaders now

2022-10-04 12_06_28-.png
 

Product Development

Whether you’re in the end-stage development of an exclusive molecule or trying to break into a new healthcare specialty, you need the right strategy to be successful. We help pharmacy compounders, outsourcing facilities, and GMP life science companies assess the financial, operational, regulatory and clinical factors of bio/pharmaceutical drug 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!

 

Turn your molecule into market share

2022-10-04 12_06_28-.png
 

Operational Efficiencies

Is your operation running as efficiently as it could?
Our experts audit your processes, equipment, workflows, and staffing to identify inefficiencies, streamline production, and uncover cost-saving opportunities. The result? Smarter operations, reduced waste, and higher output—with less effort.

 
 

What We’ll Do

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

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

  • Provide an advisory summary report.

 
 

Boost output. Cut waste. Stay compliant.

2022-10-04 12_06_28-.png
 

Personnel Training

Customized Training, Delivered On-Site or Remotely
Our consultants bring deep expertise in USP <797>, <795>, <800>, and 21 CFR Parts 210/211 to your team. We provide hands-on or virtual training tailored to your specific SOPs, equipment, and workflows. Whether you need foundational compounding education or advanced cGMP alignment, we ensure your staff is confident, compliant, and inspection-ready.

 

We’ll Teach You

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

 

Tailored training for compliance, quality, & throughput

2022-10-04 12_06_28-.png
 

Environmental Monitoring Program Design

What is the current environmental status of your cleanroom? 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, Airflow Visualization, Process/Personnel/Material Flow, and Historical Contamination Risks (if available)

  • Provide an Initial Risk Assessment for Proposed Sample Site Locations, Frequencies, and Limits

  • Conduct an Environmental Baseline Study (e.g.; EMPQ)

  • Adjust Sampling Site Map, Frequencies, and Limits Based on EMPQ Findings

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

 
 

Take the guesswork out of EM planning

2022-10-04 12_06_28-.png
 

CGMP Validation Services

We provide cost-effective CGMP commissioning and qualification services for 503B, Cell & Gene, and traditional pharmaceutical manufacturing facilities. Our engineers have deep expertise in developing and implementing validation protocols (IQ, OQ, PQ), as well as preparing compliance documentation for equipment, utilities, processes, lab instruments, and computerized systems.

 

Commissioning, Qualification, Validation

Equipment | Utilities | Lab Instruments | Computer Systems

 

  • Refrigerators, Freezers, Incubators, Stability Chambers

  • Depyrogenation Ovens

  • Autoclaves

  • Blenders, Mixers, Agitators

  • Tablet Presses & Encapsulators

  • PECs (e.g., LAFW, BSC, RABS, Isolators, Powder Hoods)

  • Filtration Systems

  • Glassware, Parts Washers

  • Aseptic Processing Equipment

  • Capping Equipment

  • Inspection Systems

  • Label & Packaging Equipment

  • Water Systems (e.g., Water Chillers, PW, WFI)

  • Compressed Air & Gas Systems

  • HVAC Systems

  • Clean-In-Place Systems

  • Steam/Sterilize-In-Place Systems

  • Environmental Baseline Studies (EMPQ)

  • GC & HPLC Instruments

  • Weighing and Dispensing Systems

  • Laboratory Information Management Systems

  • Computer Systems

  • And More

 
 

Full-service IQ/OQ/PQ support to meet GMP expectations

2022-10-04 12_06_28-.png
 

Protocol Design

Custom Protocols That Meet the Standards—and Match the Science
503A pharmacies & hospitals, 503B outsourcing facilities, and GMP life science manufacturers—including cell & gene therapy programs—must meet rigorous regulatory and accreditation expectations specific to their industry and site. Off-the-shelf master formulas and generic validation templates aren’t enough.

Restore Health Consulting develops customized protocols that reflect your specific processes, facility design, equipment, and regulatory requirements.

 

What We Do

We help ensure your protocols support quality production, compliance and accreditation requirements pertinent to your industry (e.g., FDA 21 CFR Part 210/211 or FDA section 503A of FDCA, DEA, USP <797>/<795>/<800>, state Boards of Pharmacy, NABP, PCAB, etc.)

For Pharmacies

  • Standardized master formula templates

  • Media fill protocols

  • Sterile and non-sterile process validations

For GMP Facilities

  • Aseptic Process Validation

  • Cleaning & SIP/CIP Validation

  • Environmental Baseline Studies (EMPQ)

  • Assay & Analytical Method Validation

  • Process Transfer and Shipping Validation

  • And More!

 

Get protocols that stand up to inspections.

2022-10-04 12_06_28-.png
 

SOP Customization

Compounders and GMP facilities involved in aseptic or non-sterile drug production must maintain detailed, site-specific SOPs to meet state, federal, and accreditation requirements.

Off-the-shelf SOP templates may seem convenient—but they often fall short in inspections. Your procedures must align with your actual workflows, equipment, and personnel roles.

Restore Health Consulting customizes your SOPs to reflect your facility’s unique operations and to support compliance with:

State Boards of Pharmacy

FDA and DEA expectations

USP <797>, <795>, and <800>

Accreditation standards like PCAB and NABP

 

Why Leverage a Consultant for SOP Writing?

Whether you're preparing for an inspection or building a new program, we’ll ensure your documentation is defensible, compliant, and actionable.

 

Your SOPs. Your workflow. Fully aligned.

2022-10-04 12_06_28-.png
 

NABP Accreditation

Do you need NABP accreditation to attain a certain state license but do not know where to start? We help facilities receive NABP and PCAB accreditation. Our compounding consultants have extensive auditing experience and we know what the accrediting bodies are looking for. 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 PCAB, LegitScript 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.

 

Get Accredited.

2022-10-04 12_06_28-.png
 

Adverse Drug Event Reporting

Adverse Drug Event (ADE) Response & Reporting Support
Bio/pharmaceutical manufacturers and compounders alike are required to maintain written procedures for identifying, investigating, and reporting adverse drug events (ADEs) to the FDA and certain state agencies.

We ensure your team responds swiftly, documents correctly, and reports on time. From guiding investigations to preparing for regulatory scrutiny, we help you meet compliance requirements, avoid delays, and reduce risk when ADEs occur.

 

Why Choose Us?

Our consultants have extensive experience in assisting with 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

  6. Audit Preparation

 

An ADE happened. Now what?

2022-10-04 12_06_28-.png
 

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

Whether you're preparing for an upcoming inspection or conducting due diligence for a merger or acquisition, our experts help you assess and strengthen compliance across regulatory frameworks—including cGMP, USP <797>/<795>/<800>, FDA, DEA, PCAB, and NABP.

Our team of experts—drawn from 503A, 503B, and pharmaceutical manufacturing—conducts detailed mock audits, gap assessments, and full compliance reviews tailored to your operation type and regulatory exposure.

We don’t just identify the gaps—we help you close them. From initial readiness to remediation, we ensure you’re equipped to meet your next audit with confidence.

 
 

What We’ll Do

  1. Pre-Audit - Review Documents & Prepare a Checklist

  2. Audit - Conduct a Compliance Audit

  3. Report - Provide a Review of Findings Report

  4. Fix - Remediate the Issues

 
 

Uncover gaps before regulators do

2022-10-04 12_06_28-.png
 

Expert Witness

Restore Health Consulting provides expert witness and litigation support for matters involving 503A pharmacies, 503B outsourcing facilities, and GMP-regulated life science operations—including pharmaceutical, biotech, and cell & gene therapy organizations.

Whether you're navigating legal disputes, regulatory enforcement, or professional board action, we deliver credible, experience-backed support trusted by attorneys, regulators, and healthcare operators nationwide.

 

Our Holistic Approach

 

  • Evidence Review

  • Gap Analysis Audit

  • CAPA Planning

  • Remediation Implementation

  • Compliance Reassessment

  • Current Compliance Report

  • Expert Witness Testimony

 
 

Get expert support for your legal case

2022-10-04 12_06_28-.png
 

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!

 

Get licensed in all 50 states fast

2022-10-04 12_06_28-.png
 
503A Compounding Pharmacy Probationary Monitoring Consultant

Expert Oversight During Probation, Consent Decrees, & Regulatory Enforcement

Pharmacies, hospitals, and 503Bs facing disciplinary action may be placed on probation by state Boards of Pharmacy. GMP facilities may become subject to FDA consent decrees or warning letters requiring formal remediation and ongoing oversight.

In these high-risk situations, regulators often mandate an independent, board- or FDA-approved consultant to monitor compliance, oversee corrective actions, and report progress throughout the term of enforcement.

 

Restore Health Consulting offers trusted probation and regulatory remediation support. We serve as your designated compliance partner to:

  • Fulfill board-ordered probation monitoring requirements

  • Conduct recurring audits to assess compliance with probation or consent terms

  • Provide written reports at required intervals

  • Support site remediation plans, CAPA tracking, and operational turnaround

  • Help you stay operational and regain trust with regulators

Whether you're under board scrutiny or FDA oversight, we provide experienced, defensible support to help you move forward.

 

Our Holistic Approach

 

  • Gap Analysis Audit

  • CAPA Planning

  • Remediation Implementation

  • Education

  • Compliance Report

 
 

Probation? Consent decree? We’ve got you.

2022-10-04 12_06_28-.png
 

Recalls

Whether a recall is voluntary or requested by a state regulator or FDA, compounders and pharmaceutical manufacturers must have written procedures to initiate, trace and report drug recalls to FDA and state agencies.

 

Our consultants have experience in handling and reporting 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

 

Facing a recall? Minimize damage. Act fast.

2022-10-04 12_06_28-.png
 

Regulatory Response

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

If you've received a 483, a warning letter, accusation or corrective action mandate, you’re on the clock—and the stakes are high.

We bring real-world experience from inside 503A, 503B, and GMP-regulated facilities to help you respond quickly, effectively, and credibly. We work with your team to investigate root causes, draft clear and compliant responses, and implement practical solutions that demonstrate control.

We’ve helped compounders and manufacturers turn around difficult inspections and enforcement actions—so you can move forward with confidence and get back to what matters: making safe, high-quality drugs.

 

Under FDA or Board scrutiny? Respond with expert support.

2022-10-04 12_06_28-.png
 
Compounding Pharmacy Quality Assurance Consultant

Quality System Overhaul

When warning letters, 483s, or audit findings point to serious gaps, it’s not enough to patch the issues. You need a durable, inspection-ready quality system that prevents future failures and restores regulator confidence.

Whether your system has slowly unraveled over time—or cracked under FDA or state agency pressure—we help you rebuild the structure that supports safe, compliant drug production.

 

What We Do

Restore Health Consulting helps pharmacies, outsourcing facilities, and GMP manufacturers overhaul their quality systems with actionable, scalable solutions. We get in the weeds with your team to:

  • Investigate citations or operational failures

  • Deliver a clear root cause analysis report

  • Develop a targeted CAPA plan

  • Redesign weak procedures, roles, and workflows to prevent recurrence

 

Fix the system—not just the symptoms

2022-10-04 12_06_28-.png
 

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 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 and GMP manufacturing sites may also prefer to sub this work out to a competent GMP auditor so they can focus on mass production. Our auditors hold certified quality auditor (CQA) designation and have deep GMP experience. Don’t take time away from your operation. Let us take the guess work out of auditing your critical 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

 

Know your source. Protect your product.

2022-10-04 12_06_28-.png