Products for Multi-Modal Regenerative Clinics
Regenerative medicine clinics often combine biologics, compounded peptides and device-based workflows. ExaVeyra centralizes documentation, wholesale procurement, and cold-chain logistics for approved clinical accounts.
cGMP extracellular vesicle supply with COA review, particle characterization, and cold-chain fulfillment.
Compounded peptide formulations, dispensed by our 503A pharmacy partner on a patient-specific prescription.
Exosome material, Wharton’s jelly and MSC products for sponsor-held IND studies and registered trials, subject to each manufacturer’s authorization.
Chemist-guided review of lot records, sterility, endotoxin, mycoplasma, and identity documentation.
Temperature-controlled fulfillment for biologics and practice-ready shipping coordination.
Account management for reorder planning, documentation requests, and technical product questions.
Regulatory notice
Exosome material. No exosome product is approved, cleared or licensed by the FDA for any use in humans, and statements on this site have not been evaluated by the FDA. Kimera exosome material is supplied to NPI-verified licensed practitioners for topical aesthetic use on the skin surface, including after procedures, as labeled by the manufacturer, and for laboratory research and clinical research conducted under an FDA investigational new drug application. It is not supplied for injection, infusion, inhalation, intranasal, ophthalmic or any other route into the body, and it is not intended to diagnose, treat, cure, mitigate or prevent any disease. Whether, how and in what setting it is used, and whether that use complies with scope of practice and state law, is the licensed practitioner’s responsibility. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions. Research summaries describe published studies and are not claims about any product.
Compounded preparations. Compounded preparations are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed. Each preparation is compounded and dispensed by our 503A pharmacy partner, licensed by its state Board of Pharmacy, on a patient-specific prescription from a licensed prescriber; ExaVeyra Sciences does not compound, dispense or prescribe. ExaVeyra makes no claim that any preparation is safe or effective for any condition. Availability depends on the pharmacy’s license in the destination state and on whether the substance may be compounded under federal and state law. Prescribing, patient selection and scope of practice are the responsibility of the licensed prescriber. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions.
Documentation-First Procurement for Regenerative Practices
ExaVeyra supports clinics that need transparent sourcing, pharmacy partner clarity, and lot-specific documentation before a product enters their practice workflow.
Building a Documentation-First Regenerative Medicine Supply Chain
Why cGMP matters for extracellular vesicles
Current Good Manufacturing Practice (cGMP) regulations define the minimum quality standards for pharmaceutical manufacturing, including process validation, environmental monitoring, personnel qualification, and batch release testing. For extracellular vesicle preparations, cGMP compliance means the manufacturing environment is controlled, the process is documented and reproducible, and each lot is released only after meeting defined specifications. ExaVeyra sources exclusively from FDA-registered cGMP facilities and requests process validation documentation as part of supplier qualification.
503A versus 503B: what regenerative clinics need to know
503A pharmacies prepare patient-specific compounded prescriptions under state board oversight. 503B outsourcing facilities manufacture larger batches under FDA oversight and can supply office-use quantities without patient-specific prescriptions. The distinction matters because it affects what documentation is required, what FDA oversight applies, and what indications and quantities are permissible. ExaVeyra supplies compounded preparations only through a 503A pharmacy, against a prescription for an individual patient, and does not supply office stock.
Endotoxin testing is non-negotiable for biologics applied to treated skin
Endotoxins are lipopolysaccharide fragments from gram-negative bacterial cell walls that cause fever and inflammatory responses at very low concentrations. For any biologic applied to skin after microneedling, laser, or other procedures that open the skin barrier, endotoxin content must be quantified using a validated limulus amebocyte lysate (LAL) assay or recombinant Factor C (rFC) assay. An endotoxin result of "pass" without a stated acceptance limit and assay method provides no basis for independent verification. ExaVeyra requests quantitative endotoxin data with stated acceptance criteria for every lot.
What a full COA library looks like
A complete COA library for a regenerative medicine practice should include, for each product category: HPLC, RNA quantification assay, and NanoSight NTA characterization (for EVs), potency assay with methodology (for peptides), sterility testing under USP <71> or equivalent, endotoxin quantification with acceptance criteria, mycoplasma screening results, identity confirmation by mass spectrometry or HPLC, and lot traceability from the manufacturing batch record. ExaVeyra builds this documentation set during supplier onboarding and makes it available to approved accounts on request.
Benn Bluestein-Veyra, M.Sc. Organic Chemistry. Founder, ExaVeyra Sciences.
Recommended for Regenerative Medicine Clinics
All products require NPI verification and approved wholesale account. COA, lot documentation, and shipping guidance are available for approved practices.
Exosomes
cGMP MSC-derived extracellular vesicle preparations with lot-specific COA documentation and cold-chain fulfillment.
Compounded Peptide Formulations
503A compounded peptide formulations. Third-party testing documentation available on request.
Peptide Formulary
Peptide formulations for approved clinical accounts, with documentation on request.
CuraCator Applicator
A sterile, single-use, FDA-listed Class I applicator that spreads a liquid as an even layer on the skin after procedures.
A Supply Chain Built for Regenerative Practices
M.Sc. Chemist Review
Supplier documentation is evaluated through a technical, chemistry-led review process.
NPI-Verified Access
Wholesale access is limited to licensed practitioners and approved clinical entities.
COA Per Lot, On Request
Lot-specific documentation supports internal review and procurement records.
Cold-Chain Fulfillment
Temperature-controlled shipping supports biologic integrity during transit.
Our 503A Pharmacy Partner
Compounded peptides are dispensed by our 503A pharmacy partner on a patient-specific prescription.
Account Management
Approved partners receive reorder planning and documentation support.
Questions from Regenerative Medicine Clinics
What is the difference between 503A and 503B compounding?+
503A pharmacies prepare patient-specific compounded prescriptions under state pharmacy board oversight and are limited to dispensing pursuant to valid prescriptions for identified patients. 503B outsourcing facilities are FDA-registered and can manufacture larger batch quantities for office use without patient-specific prescriptions, under FDA inspection and cGMP requirements. The practical difference for regenerative medicine clinics is that 503B supply supports consistent lot-to-lot office-use procurement, while 503A supply is appropriate for patient-specific compounded preparations. ExaVeyra supplies compounded preparations only through a 503A pharmacy, against a prescription for an individual patient, and does not work with a 503B outsourcing facility.
How are ExaVeyra exosomes sourced for regenerative medicine clinics?+
ExaVeyra evaluates extracellular vesicle supplier documentation before approving a lot for distribution. The evaluation includes cGMP facility registration, source material traceability, HPLC and RNA quantification assay documentation, NanoSight NTA methodology, sterility testing under USP <71> or equivalent, mycoplasma screening, and endotoxin quantification with acceptance criteria. Approved lots are supplied with this documentation available for clinic review. The evaluation is conducted by our founder, an M.Sc. organic chemist with analytical chemistry and biochemistry expertise.
What COA documentation is included with regenerative medicine products?+
COA documentation for regenerative medicine products may include HPLC, RNA quantification assay, and NanoSight NTA characterization (for extracellular vesicles), potency assay with methodology (for peptides and small molecules), sterility testing results, mycoplasma screening results, endotoxin quantification with acceptance criteria, identity confirmation by HPLC or mass spectrometry, manufacturing date and lot number, expiration dating, and shipping validation records where applicable. The specific documentation available varies by product category and lot. Approved accounts can request the full documentation package for any product before placing an order.
What is the minimum order for regenerative medicine clinics?+
Minimum order quantities vary by product category, format, and lot availability. Extracellular vesicle preparations are supplied in liquid format and have MOQs set by the manufacturing batch size. Compounded peptide quantities follow the patient-specific prescription and the pharmacy partner's dispensing terms, and availability varies by state. Devices are available in standard case quantities. Apply for NPI-verified wholesale access to receive current MOQ, tiered pricing, and volume discount information for your practice volume and product mix.
How do biologics ship to regenerative medicine clinics?+
Liquid extracellular vesicle preparations ship cold-chain in temperature-monitored packaging with expedited fulfillment. Compounded peptides ship from our pharmacy partner, cold-chain for sterile preparations and ambient for lyophilized formats, depending on the specific compound and lot. Devices ship at ambient temperature by standard carrier. Shipping requirements and cold-chain configuration are confirmed per order by your account manager.
Can regenerative medicine clinics get documentation support?+
Approved wholesale partners receive a dedicated account manager and can coordinate technical documentation questions with our chemist team. ExaVeyra does not provide medical advice, clinical protocols, or treatment recommendations. Clinical decisions, patient selection, protocol design, and regulatory compliance for specific procedures remain the responsibility of the licensed practitioner. Our support covers procurement, documentation, and supply chain questions.