Most GMP consulting firms grew out of large pharma. Their mental model assumes:

• Billion-dollar budgets

• Single product pipelines

• Long development cycles

• Departmental org charts

• Annex 1–style aseptic operations, but not daily compounding realities

Personalized medicine manufacturing and compounding environments—especially 503A/503B models—are different. They require:

• Rapid changeovers

• High-mix, low-volume manufacturing or compounding

• Daily multi-batch production

• Direct-to-patient or -clinic workflows

• Real-time decision-making under scrutiny

• Navigating FDA + State Boards + USP (simultaneously)

RHC does this work every day — across dozens of facilities simultaneously.

We understand the nuance: BUD risk assessments; master formulation records; extractables, leachables, and container closure compatibility traps; batch size constraints; vial/stopper sourcing; segregated hazardous workflows; EM trending that has to make sense for compounding; real-world gowning behaviors; and staff who may not have a pharma background and are asked to perform manual aseptic manipulations.

No individual contractor or pharma-focused consultancy brings that level of tailored expertise.

Hiring an independent contractor means:

• If they get sick, you're stuck.

• If they’re busy with another client, timelines slip.

• If they leave unexpectedly, your project progress walks out the door with them.

• There’s no cross-checking, peer review, or second set of eyes on critical decisions.

Traditional firms also struggle here: you often receive a rotating cast of junior consultants learning on your dime.

RHC solves these problems with a team-based consulting model:

• Multiple experts available to support your project

• Quality, operations, regulatory, and engineering depth

• Peer review of deliverables available

• Schedule resilience — your project never stalls

• Continuity planning — institutional knowledge never leaves with one person

This dramatically reduces project risk—especially in sterile compounding, where a single oversight can trigger costly remediation, regulatory action, or production shutdowns.

Individual contractors often need 4–8 weeks to “learn your operation.”
Large GMP firms spend months performing assessments that re-explain baseline GMP principles.

RHC brings:

• Pre-built templates

• Playbooks proven across 100+ compounding clients

• Benchmarking from top-performing facilities

• Deep familiarity with state-specific nuances

• A mental model of what “good” looks like for your exact operation

• A 503B startup pathway that avoids wasted time and unforced errors

This means we execute faster so you can make decisions sooner, and not over-engineer your systems.

You get speed without sacrificing compliance.

Independent contractors may appear inexpensive—but only at the hourly rate. The hidden costs add up quickly:

• Rework

• Slow execution

• Gaps in regulatory coverage

• No redundancy

• Limited availability

• Incomplete documentation

Traditional GMP firms, meanwhile, usually bring pharma-level overhead and pricing, plus consultants who do not understand compounding’s or ATMP’s unique requirements.

RHC is positioned in the strategic middle:

• Lower cost than big box firms

• Far more capability and safety net than an individual

• Purpose-built methodology that avoids waste

You pay for true expertise, not bureaucracy or learning curves.

Traditional firms often sell you the senior partner… then staff your project with a junior consultant.

Independent contractors may have experience, but often lack breadth.

RHC places senior expertise on every project such as:

• Former 503B leaders

• Cell & gene pioneers

• Pharmacists with BCSCP or compounding specialization

• Engineers with aseptic and facility design backgrounds

• USP <797>/<800> and contamination control specialists

• Consultants who have stood in front of FDA, DEA or Boards of Pharmacy

• Experts who have actually managed sterile operations

Deliverables reflect senior-level judgment—not entry-level guesswork.

Traditional GMP firms tend to:

• Overcomplicate workflows

• Recommend unnecessary capital equipment

• Default to pharma-level documentation

• Apply Annex 1 dogma without understanding compounding realities

Individual contractors may underbuild systems because they lack cross-facility benchmarking.

RHC strikes the right balance.

We build systems that are:

• FDA-ready AND Board-of-Pharmacy-ready

• Compliant but not overengineered

• Scalable as you grow

• Practical for teams with mixed experience

• Designed specifically for high-mix compounding operations

This prevents both extremes: undercompliance and overkill.

Where others may exploit scope ambiguity, we actively manage it:

• We outline what the work actually takes, not an unrealistically low teaser number.

• We provide routine updates on hours and progress.

• We scope in phases so you stay in control of pace, spend, and priorities.

• We don’t “pad” hours or create unnecessary work to keep a project alive.

• We proactively identify cost-saving shortcuts and “quick wins.”

• We use open scopes when the nature of the work genuinely requires flexibility.

Independent contractors can quietly accumulate hours with no oversight.
Large firms often turn vague scopes into runaway budgets.

RHC provides the flexibility of open-ended work with the discipline of a structured firm.
You know:

• What we’re doing

• Why we’re doing it

• How many hours it’s taking

• What the expected next milestone is

This ensures you get high-value consulting without scope creep, surprises, or wasted spend.

Most GMP firms are purely technical.
Most contractors are purely task-based.

RHC understands how compounding and personalized medicine businesses operate:

• Throughput and changeover

• Facility layout optimization

• Batch size economics

• Contamination control strategy

• Telehealth workflows

• Compounding frameworks during and after drug shortages

• Vertical integration with telemedicine

• Inventory and cost-of-goods challenges

• HR issues in staffing

• De-risking the business before acquisition or sale

This makes RHC a strategic advisor, not just a compliance vendor.

503B outsourcing facilities and sterile 503A pharmacies are subject to:

• FDA inspections

• State inspections

• NABP VPP

• USP reviews

• Telehealth partnership audits

• DEA requirements

• Payer/contractual oversight

You don’t get a second chance with regulators or payors.

RHC provides:

• Inspection readiness

• Mock audits

• EM program design and trending

• Aseptic behavior and gowning remediation

• Facility and equipment qualification oversight

• Supplier qualification and technical agreements

• Sterility assurance expertise

• Corrective action strategy that regulators actually accept

This level of support is not possible with a solo consultant or a pharma-centric firm unfamiliar with compounding or cell therapy regulators.

Independent contractors rely on maximizing billable hours.
Traditional GMP firms want multi-million dollar, multi-year engagements.

RHC’s goal is simpler:

Help your operation reach sustained compliance, robustness, and scalability—with the highest ROI and the least disruption.

We structure engagements to:

• Build your internal competency

• Train your team

• Create systems you can maintain yourself

• Reduce your dependency on external consultants

• Leave you stronger than when we arrived

This aligns incentives around your success—not ours.