Introduction: The Catalyst Clinic's Commitment to Compliance in Peptide Therapy

At The Catalyst Clinic, we understand the importance of compliance with regulatory standards set forth by both the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the Food and Drug Administration (FDA) in the United States. Our commitment to adhering to these regulations ensures that our peptide therapies are not only effective but also safe for our patients.By meticulously following the guidelines established by the MHRA and FDA, The Catalyst Clinic emphasizes quality, safety, and efficacy in all aspects of our peptide therapy offerings. This includes strict adherence to Good Manufacturing Practices (GMP), comprehensive clinical trial protocols, and rigorous post-marketing surveillance.We prioritize transparency and excellence in our practices, ensuring that every peptide therapy we provide meets the highest standards set by these regulatory bodies. Our dedication to compliance not only reflects our commitment to patient care but also reinforces our role as a trusted provider in the peptide therapy landscape. At The Catalyst Clinic, we believe that rigorous adherence to regulatory standards is fundamental to delivering innovative and reliable healthcare solutions.

UK ComplIAnce (MHRA)

Our Commitment

At The Catalyst Clinic, we operate with full transparency and integrity in every aspect of our medical and advisory services.
We follow the guidance of the Medicines and Healthcare products Regulatory Agency (MHRA), the Advertising Standards Authority (ASA), and the Care Quality Commission (CQC) to ensure that all information provided on this website is factual, evidence-based, and compliant with current UK regulations.

Our aim is to offer clinician-supervised wellness and educational consultations, not to advertise or promote unlicensed medicinal products.
All references to peptides or biologically active compounds are presented for educational and informational purposes only.

Regulatory Status of Peptides

Certain peptides discussed within consultations or educational material are not licensed as medicinal products in the United Kingdom.
They may only be prescribed or reviewed within a regulated clinical consultation and under the supervision of a qualified prescriber.

  • Peptides referenced are intended for research or clinician-guided use only.

  • They are not marketed or sold to the general public.

  • No statements on this site claim medical efficacy or guaranteed results.

  • All discussions occur under strict medical oversight with appropriate diagnostic monitoring.

Advertising and Marketing Compliance

The Catalyst Clinic adheres to:

  • The UK Code of Non-Broadcast Advertising (CAP Code)

  • The Human Medicines Regulations 2012 (as amended)

  • The MHRA Blue Guide (2024 edition)

We ensure that:

  • No medicine or peptide is advertised to the public.

  • All health-related claims are supported by credible, peer-reviewed evidence.

  • Website language is structured for education and awareness, not promotion.

  • References to potential benefits are qualified as “under investigation” or “based on emerging research.”

Consultation Policy

Every patient must complete a medical consultation and diagnostic assessment before any peptide or longevity protocol is discussed.
Each consultation is:

  • Conducted by a licensed medical professional.

  • Based on individual biomarkers and medical history.

  • Designed to ensure safety, appropriateness, and transparency.

No treatment, supplement, or peptide is provided without prior clinical evaluation.

Scientific Integrity

We are committed to responsible innovation in the fields of longevity and regenerative medicine.
All educational materials are based on peer-reviewed scientific literature and are periodically updated to reflect current research.
Each publication or page is medically reviewed before being made public.

Data Protection & Patient Safety

The Catalyst Clinic complies with UK GDPR, CQC data-handling standards, and maintains strict confidentiality for all patient and diagnostic data.
Information is used exclusively for clinical or administrative purposes and is never shared with third parties without explicit consent.

Disclaimer

All content on this website is intended for educational purposes only and should not be interpreted as medical advice.
The Catalyst Clinic does not claim to diagnose, treat, cure, or prevent any disease.
Any therapeutic discussion or intervention occurs solely within a private medical consultation with a qualified clinician.

For official information about licensed medicines in the UK, please visit:
👉 www.gov.uk/mhra

Contact

Compliance Enquiries:
📧 hello@thecatalystclinic.com
📍 The Catalyst Clinic, London, United Kingdom

US CompliAnce (FDA)

Compliance in Peptide Therapy in the US: FDA Guidelines

In the United States, peptide therapy is governed by the regulations set forth by the Food and Drug Administration (FDA). This compliance page outlines the key aspects of FDA regulations regarding peptide therapies.

Regulatory Overview
The FDA is responsible for ensuring the safety, efficacy, and quality of drugs and medical products, including peptide therapies. Peptides that are intended for therapeutic use are typically classified as drugs and must comply with the FDA's rigorous standards.

Classification of PeptidesPeptides can be classified in various ways based on their intended use:

  • Therapeutic Peptides: These are designed to treat specific medical conditions and are regulated as drugs.

  • Research Peptides: These are used for research purposes and may not require FDA approval, but must still comply with certain regulations depending on their use.

Preclinical and Clinical Development Before a peptide therapy can be marketed, it must undergo a series of stages including:

  1. Preclinical Studies: Initial research to evaluate safety and biological activity.

  2. Investigational New Drug (IND) Application: This must be submitted to the FDA before beginning clinical trials. It includes data from preclinical studies and outlines the proposed clinical trial.

  3. Clinical Trials: Conducted in phases to test safety and efficacy in humans. The FDA must approve the trial protocols and monitor the data collected.

New Drug Application (NDA)

Once clinical trials are successfully completed, a New Drug Application (NDA) must be submitted to the FDA for review. This application includes comprehensive data on the peptide's safety, efficacy, manufacturing processes, and labeling.

Good Manufacturing Practice (GMP)

Manufacturers of peptide therapies must adhere to Good Manufacturing Practice (GMP) regulations. These regulations ensure that products are consistently produced and controlled according to quality standards, minimizing risks involved in pharmaceutical production.

Post-Marketing Surveillance

After a peptide therapy is approved and on the market, the FDA continues to monitor its safety through post-marketing surveillance. Manufacturers are required to report any adverse events and maintain a system for monitoring the long-term effects of the therapy.

Enforcement and Penalties

Non-compliance with FDA regulations can lead to significant consequences, including:

  • Warning Letters: Issued for violations of FDA regulations.

  • Fines and Penalties: Monetary fines can be imposed for serious infractions.

  • Product Seizure: The FDA has the authority to seize products that violate regulations.

  • Criminal Prosecution: In severe cases, individuals and companies can face criminal charges.

Conclusion

Compliance with FDA regulations is critical for the safe and effective use of peptide therapies in the United States. Manufacturers, healthcare providers, and researchers must adhere to these guidelines to ensure that peptide products meet the necessary standards of safety, efficacy, and quality.