INTRODUCTION Regulatory Transparency at The Catalyst Clinic

The Catalyst Clinic is committed to operating with complete transparency in a field where regulatory clarity is often absent. This page sets out our compliance position in full — covering UK MHRA and ASA requirements, US FDA standards, and European EMA frameworks — so that patients, regulators, and professional bodies can understand exactly how we operate and why. We believe that a clinic which explains its regulatory position clearly is a clinic patients can trust. This page is not a formality. It is a reflection of how we practise.

SECTION 1 — UK MHRA COMPLIANCE

Regulatory status of peptide compounds

The peptide compounds discussed at The Catalyst Clinic are not licensed medicines under the Human Medicines Regulations 2012. They have not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for human use in a therapeutic, aesthetic, or wellness context. This applies to all compounds discussed in our consultations, including those that hold limited regulatory approval in other jurisdictions — that approval does not transfer to UK law.

The Catalyst Clinic does not advertise, promote, or supply unlicensed medicinal products to the general public. All references to peptide compounds on our website and in our consultations are presented for educational and informational purposes only, within the context of a registered medical practice.

Our service is advisory, not prescriptive

The Catalyst Clinic provides clinician-supervised advisory consultations. We do not diagnose conditions, prescribe unlicensed medicines for therapeutic purposes, or make efficacy claims about unlicensed compounds. Every consultation is conducted by a GMC-registered physician and is based on an individual patient's diagnostic data, medical history, and health goals.

Advertising standards compliance

The Catalyst Clinic adheres to the following in all marketing and web communications:

The UK Code of Non-Broadcast Advertising (CAP Code), administered by the Advertising Standards Authority (ASA). The Human Medicines Regulations 2012 (as amended). The MHRA Blue Guide on advertising medicinal products (2024 edition). ASA guidance on health and beauty claims.

Specifically, we ensure that no unlicensed medicinal product is advertised to the general public. All health-related claims are qualified as being under investigation or based on emerging preclinical or clinical research. No outcome, efficacy, or results-based claims are made for unlicensed compounds. Website language is structured for education and clinical context, not promotion or conversion.

Consultation and diagnostic policy

A comprehensive diagnostic assessment — including full blood work — is mandatory before any peptide-related consultation begins at The Catalyst Clinic. No advisory protocol is built without a clinical baseline. Blood work is reviewed every 4–5 months as a standard part of ongoing clinical oversight. This is not optional and is included in the monthly program fee.

Every consultation is conducted by a licensed medical professional, based on individual biomarkers and medical history, and documented in accordance with GMC standards of clinical record-keeping.

Pharmacovigilance

The Catalyst Clinic maintains a system for monitoring and documenting patient outcomes and adverse events in accordance with MHRA guidance. Any suspected adverse reactions are documented, reviewed by the responsible clinician, and reported to the MHRA Yellow Card Scheme where appropriate. Patients are encouraged to report any unexpected responses directly to their treating physician and to the Yellow Card Scheme at yellowcard.mhra.gov.uk.

Data protection

The Catalyst Clinic complies with the UK General Data Protection Regulation (UK GDPR) and maintains strict confidentiality for all patient and diagnostic data. Information is used exclusively for clinical and administrative purposes and is never shared with third parties without explicit patient consent.

SECTION 2 — ASA COMPLIANCE

Advertising Standards Authority — our position

All marketing communications produced by The Catalyst Clinic — including website copy, social media content, email communications, and any paid advertising — are produced in compliance with the CAP Code administered by the Advertising Standards Authority.

We specifically ensure the following. No absolute superiority claims are made without documentary evidence to substantiate them. No before-and-after imagery is used in connection with prescription-only or unlicensed medicinal products. Testimonials and patient accounts do not make efficacy claims for unlicensed compounds. All claims about clinical credentials and professional memberships are accurate and verifiable. Media appearances and press coverage are only referenced where a direct link to the specific article can be provided.

Where the ASA issues updated guidance relevant to our field — including guidance on health and beauty advertising, peptide or biohacking content, or influencer marketing — we review and update our communications accordingly.

SECTION 3 — US FDA COMPLIANCE

FDA framework for peptide compounds

In the United States, the Food and Drug Administration (FDA) is responsible for the regulation of drug products, including peptide compounds intended for therapeutic use. The regulatory landscape for peptides in the US is complex and has evolved significantly in recent years, particularly following the FDA's 2023 revisions to its list of bulk drug substances that may be used in compounding.

Our sourcing position

Where compounds are prescribed and sourced as part of a patient's consultation program, The Catalyst Clinic works exclusively with FDA-registered, ISO-9001-certified, GMP-compliant compounding pharmacies in the United States. These pharmacies operate under Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act, as applicable, and are subject to FDA inspection and quality oversight.

Distribution is managed through licensed FDA-regulated partners. Every compound is traceable from synthesis to delivery and meets pharmaceutical-grade standards of purity, potency, and sterility. We do not source from research chemical suppliers, unregistered compounding operations, or any pharmacy that cannot provide full regulatory documentation on request.

FDA approval status of individual compounds

Where a compound discussed at The Catalyst Clinic holds FDA approval — such as Tesamorelin (approved under Egrifta for HIV-associated lipodystrophy) or Sermorelin (previously approved, since withdrawn) — that approval applies solely to the specific licensed indication stated. It does not extend to the consultation areas discussed at The Catalyst Clinic. All other compounds discussed are not FDA-approved for any therapeutic indication and are discussed in an educational and research context only.

Good Manufacturing Practice

All compounds sourced through The Catalyst Clinic's US pharmacy partners are manufactured in accordance with FDA Good Manufacturing Practice (GMP) regulations. This ensures that compounds are produced to consistent quality standards, with full batch documentation, independent quality control testing, and contamination controls. Pharmaceutical-grade is not a marketing term — it is a verified manufacturing standard, and we do not accept compounds that do not meet it.

SECTION 4 — EMA COMPLIANCE

European Medicines Agency — framework and position

The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed for use in the European Union. Peptide compounds discussed at The Catalyst Clinic are not EMA-approved for use in a general wellness or longevity context. Where individual compounds hold EMA approval or approval in specific EU member states — such as Cerebrolysin or Thymosin Alpha-1 in certain jurisdictions — that approval applies solely to the licensed indication and jurisdiction stated.

Our European sourcing standards

Where compounds are sourced through European pharmacy partners, The Catalyst Clinic works exclusively with EMA-regulated compounding pharmacies that operate in accordance with EU GMP standards and applicable national pharmaceutical regulation. Distribution is managed through licensed, EMA-regulated partners. The same traceability and pharmaceutical-grade standards applied to our US sourcing are applied without exception to our European sourcing.

Post-Brexit regulatory position

Following the United Kingdom's departure from the European Union, UK medicines regulation is governed by the MHRA independently of the EMA. EMA approval does not constitute MHRA approval and vice versa. The Catalyst Clinic operates under MHRA jurisdiction in the UK and references EMA standards solely in the context of our European compound sourcing.

SECTION 5 — PHARMACEUTICAL-GRADE SOURCING: OUR STANDARD

What pharmaceutical-grade means

Pharmaceutical-grade is a specific, verifiable manufacturing standard — not a marketing descriptor. A pharmaceutical-grade compound is produced to documented purity and potency specifications, independently tested for quality and contamination, manufactured under GMP-compliant conditions that are subject to regulatory audit, and distributed through licensed, regulated supply chains with full batch traceability.

The alternative — research-grade compounds obtained through unregistered suppliers — carries none of these protections. Potency can vary significantly between batches. Contaminants that would be detected and rejected in a regulated facility pass unnoticed. Sterility cannot be guaranteed. At The Catalyst Clinic, we consider this standard non-negotiable.

Our sourcing commitment

We will not source from any pharmacy that is not FDA-registered or EMA-regulated. We will not discuss compounds we cannot trace to a verified, regulated origin. We will not advise on a protocol we cannot support with a documented, compliant supply chain. If you are consulting with any clinic about peptide-related programs, we strongly advise asking them directly where their compounds are sourced, what the regulatory status of their pharmacy is, and whether they can provide documentation on request.

SECTION 6 — GENERAL DISCLAIMER

All content on this website and in our consultations is intended for educational purposes only. It should not be interpreted as medical advice, a treatment recommendation, or a prescribing guide. The Catalyst Clinic does not claim to diagnose, treat, cure, or prevent any disease or medical condition.

Any therapeutic discussion or intervention occurs solely within a private medical consultation conducted by a qualified, GMC-registered clinician. The compounds discussed are not licensed medicines under the Human Medicines Regulations 2012 and are not approved by the MHRA, FDA, or EMA for general therapeutic use.

For official information about licensed medicines in the UK, visit www.gov.uk/mhra. To report a suspected adverse reaction, visit yellowcard.mhra.gov.uk.

Compliance enquiries hello@thecatalystclinic.com The Catalyst Clinic, 96 Kensington High Street, London W8 4SG

Last reviewed: May 2026 Next scheduled review: November 2026 Responsible officer: Dr. Ethan Hausman-Marquis