Lab · USP 795/797Formulation development
New preparations taken from idea to a validated master formula.
- Sterile & non-sterile formulas
- Stability studies & BUD strategy
- Peptide, GLP-1 & hormone programs
Pharmacist-ledEvery engagement led by a pharmacist licensed in 20 states
503A & 503BSterile, non-sterile and hazardous drug programs
Built, not just advisedFacilities designed, licensed and operated firsthand
20-state licensureHands-on knowledge of multi-state pharmacy rules
Services
Every stage of a pharmacy, from formula to market.
Hire us for one piece, such as a USP 797 audit, or for the whole project, from empty shell to commercial-scale production.
Lab · USP 795/797
Production · 503BScale-up & commercialization
Moving a product from small batches to steady commercial volume.
- Batch-size and process scale-up
- 503A to 503B transition planning
- Product launch & pricing support
Cleanroom · ISO 5/7/8Facility design & engineering
Cleanrooms and labs planned to pass before the first wall goes up.
- ISO 5 / 7 / 8 room planning
- HVAC, pressure cascades & equipment
- Contractor oversight & certification
Permits · 50 statesRegulatory & licensing
Pharmacy permits and registrations in every state you ship to.
- All-50-state pharmacy licensing
- DEA registration & FDA 503B filings
- FDA 483 & Board inspection response
Audit · USP 797/800Compliance audits & quality systems
Independent audits and written programs your staff can follow.
- USP 795 / 797 / 800 gap audits
- Mock inspections
- SOPs, EM programs & training
Systems · ERPSoftware & operations integration
Systems that connect intake, compounding, QA and shipping.
- Pharmacy software & ERP selection
- Operational dashboards & reporting
- Workflow automation with AI tools
Fulfillment · RxTelehealth fulfillment
Pharmacy back ends for virtual-care and wellness platforms.
- Prescriber-to-pharmacy workflow
- Multi-state dispensing compliance
- Fulfillment capacity planning
Cold chain · 2–8 °CDistribution & logistics
Getting finished product to patients and clinics nationwide.
- Cold-chain shipping procedures
- Warehouse & inventory setup
- Carrier and packaging validation
Build · Buy · SellTurnkey pharmacies & transactions
Full builds, acquisitions and sales handled by one team.
- Pharmacy start-up, end to end
- Due diligence for buyers & investors
- Exit preparation for owners
Why MK Pharmacy Advisory
Advice from someone who has signed the permit applications himself.
Most consultants have inspected pharmacies. We have built, licensed and run them. That changes the advice: fewer theoretical findings, more fixes your team can carry out next week.
- Owner-operator experienceWe plan around payroll, cash flow and staffing, not only the regulation.
- One point of accountabilityDesign, licensing, quality and launch handled by the same team, so nothing falls between vendors.
- Regulator-ready documentationEvery SOP, log and record is written the way an inspector will read it.
- Local, with national reachBased in Tampa Bay, supporting clients and licenses across the country.
- Pharmacy plus technologyAn engineering and tech background means facility systems, software and telehealth platforms get the same scrutiny as compliance.
Real experience
Check our real experience across different facilities.
Every photo here comes from a facility Amer has built, scaled, operated or owned. None of it is stock imagery. This is the work behind the advice.
Planning a build of your own? Walk through it with us →
What we audit against
The standards behind every recommendation.
| Standard | Covers | Applies to |
|---|---|---|
USP <795> | Non-sterile compounding: facilities, components, BUDs, documentation | 503A pharmacies |
USP <797> | Sterile compounding: garbing, aseptic technique, environmental monitoring, BUDs | 503A pharmacies |
USP <800> | Hazardous drugs: containment, negative-pressure rooms, PPE, deactivation | 503A & 503B |
21 CFR 210/211 | Current good manufacturing practice, batch records, quality unit | 503B outsourcing facilities |
ISO 14644-1 | Cleanroom particle classification and certification | Any sterile operation |
F.S. 465 · 64B16 | Florida pharmacy law and Board of Pharmacy rules | Florida-permitted pharmacies |
What you receive
Concrete work product, not slide decks.
Every engagement ends with documents and systems your team keeps using after we leave.
Gap reportFindings ranked by inspection risk, each with a fix, an owner and a target date.
SOP libraryFacility, personnel, compounding, cleaning and QA procedures tailored to your operation.
Master formulation recordsFormulas, compounding records and BUD justifications for each preparation.
EM programViable and non-viable sampling plans, maps, action levels and trending templates.
Training kitGarbing, aseptic technique and hazardous drug competency packages with sign-off records.
Licensing packetCompleted applications, supporting policies and inspection checklists for each state.
How an engagement runs
From first walkthrough to passed inspection.
Assess
Site visit or document review, then a written gap report ranked by risk.
Plan
Scope, budget and timeline for design, licensing and quality systems.
Build
We work alongside your contractor, certifier and staff through construction and validation.
Inspect-ready
Mock inspection, final corrections and support on inspection day.
Ways to work with us
Choose the level of involvement you need.
Hourly consultation
Quick answers on a regulation, a floor plan or a vendor quote. Ideal before you sign a lease or a contract.
- Video or on-site sessions
- Written follow-up notes
Fixed-scope project
A defined outcome, such as a USP 797 audit, a state license or a full cleanroom build, with a set fee and timeline.
- Scope, schedule and fee agreed up front
- Weekly progress updates
- Inspection-day support included
Compliance retainer
Continuing oversight for pharmacies that want an experienced pharmacist reviewing their program every month.
- Monthly audits & EM trend review
- SOP updates as standards change
Project experience
Work we've led from the ground up.
503B · Palm Harbor, FL
Outsourcing facility, built from an empty shell
Led design, cleanroom construction, quality systems and FDA registration for a sterile 503B outsourcing facility, working directly with the cleanroom contractor through certification.
503A · Co-owner
Co-owned compounding pharmacy
Co-owned a 503A compounding pharmacy and was involved in its compounding operations, compliance and growth. That ownership experience shapes how we advise other pharmacy owners.
Telehealth · Founder
GLP-1 & peptide telehealth platform
Founded a telehealth platform and built both sides of it: the technology and the pharmacy fulfillment model, from prescriber workflow to patient shipping.
Who we serve
Clients across the compounding world.
From a single pharmacist opening a first location to investors evaluating an acquisition.
503A compounding pharmacies503B outsourcing facilitiesDrug manufacturersTelehealth companiesWellness brandsSpecialty pharmaciesVeterinary pharmaciesPharmacy start-upsPrivate equity & investorsInternational healthcare companies
Amer Maksoud, RPh
Founder · Pharmacist licensed in 20 statesAmer is a pharmacist licensed in 20 states with a background in engineering and technology. He has served as Pharmacist-in-Charge, built a 503B outsourcing facility in Palm Harbor from the ground up, and previously co-owned a 503A compounding pharmacy. He is also the founder of a GLP-1 and peptide telehealth platform, where he leads both the technology and the pharmacy operations. MK Pharmacy Advisory brings that mix of pharmacy, engineering and tech to every client.
RPhLicensed in 20 statesPharmacist-in-Charge503A · 503BTelehealth founderEngineering & tech
FAQ
Questions we hear before most engagements.
Do you work outside Florida?
Yes. We're based in the Tampa Bay area and support clients nationwide, including non-resident licensing in other states.
Should I open a 503A or a 503B?
It depends on whether you'll dispense patient-specific prescriptions or supply office-use stock to clinics and hospitals. We walk through volume, product list, capital and regulatory load with you before you commit.
How long does a sterile build-out take?
Most 503A cleanroom projects run several months from design to certification. Permitting and Board inspection add time, so we plan those in parallel.
Can you audit a pharmacy that's already open?
Yes. A gap audit or mock inspection gives you a ranked list of findings and fixes before a regulator finds them.
Is our first conversation confidential?
Yes. We're glad to sign an NDA before reviewing your plans or documents.
Can you help us prepare for a Board or FDA inspection next month?
Yes. A focused mock inspection and corrective plan can be completed in a few weeks. The sooner we start, the more findings you can close before the visit.
Do you work with our existing contractor and architect?
Yes. We review drawings, attend site meetings and sign off on punch lists alongside the team you already have.
We received an FDA 483. Can you help with the response?
Yes. We help you investigate root causes, write corrective actions and draft a response within FDA's 15-business-day window.
Do you advise investors on pharmacy acquisitions?
Yes. Our due diligence covers licenses, compliance history, facility condition and operational risk before you close.
Contact
Tell us about your project.
A pharmacist reviews every inquiry. Consultations are confidential.
- Office
- 2300 Curlew Rd, Palm Harbor, FL
- amer@mkpharmacyadvisory.com
- Phone
- (412) 712-3771