Myloy Health is a Malta-based pharmaceutical consultancy providing Regulatory Affairs, Pharmacovigilance, Quality Assurance, GMP, GDP, GVP and Computerized Systems Validation (CSV) services to pharmaceutical, medical device and food product companies worldwide.
With more than 18 years of industry experience, we help companies achieve and maintain regulatory compliance while bringing their products to market efficiently and confidently.
What do we do? We Support Pharma Companies & Life Science Professionals with our Solutions.
In an era of growing regulatory requirements, pharmaceutical companies and regulatory professionals are under more pressure than ever. From meeting evolving GxP requirements to ensuring product safety and managing global submissions, the regulatory burden is rising and internal teams sometimes need support in order to keep up.
That’s where we come in. We provide end-to-end regulatory, pharmacovigilance, and GxP compliance services designed to support your team, reduce risk, and speed up your time to market.
Regulatory Affairs Services
Helping you register faster, respond smarter, and grow globally.
We support both small teams and large pharma companies with:
- End‑to‑end Regulatory Affairs Services
- Accessing new markets by MAA Support & Lifecycle Management – Variations, renewals, line extensions
- CTD/eCTD Dossier Preparation – Authoring, compilation, publishing
- Global Regulatory Submissions – EMA, MHRA, FDA, GCC, TGA and more
- Regulatory Intelligence – Keep up with changing regulations in key markets
- Authority Interactions – Scientific advice meetings, deficiency responses
- Translations of Product Information – including Linguistic reviews and Quality (QA) checks
- Review of artwork and promotional material
- Regulatory support activities for medical devices, food supplements and cannabis-based products
Pharmacovigilance (PV) Services
Taking care of the safety, compliance and reputation.
Today’s pharmacovigilance challenges include rising reporting obligations, signal detection pressures, and inspection readiness. Our PV solutions are built to help your QPPV, safety officers, and PV teams focus on what matters.
We offer:
- End‑to‑end PV services including EU QPPV and deputy
- Individual Case Safety Reports (ICSR) processing
- Literature Monitoring & Signal Detection
- PSUR / DSUR / RMP Authoring & Submissions
- Local PV Compliance Support across the EU and international markets
- 24/7 Safety Support and Audits to ensure inspection readiness
GMP & GDP Compliance Support
Quality is non-negotiable. Let us help you stay inspection-ready.
Whether you’re manufacturing or distributing, you must comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. But with evolving guidelines, workforce turnover, and frequent audits, maintaining compliance is challenging.
We support:
- End‑to‑end GxP services
- EU GMP certification of your manufacturing site
- EU GDP certification of your distribution site
- GMP/GDP Gap Assessments & Audits
- QMS Development and SOP Writing
- Deviation, CAPA, and Risk Management Systems
- Supporting QPs with GMP Compliance activities
- Supporting RPs with GDP Compliance activities
- Computerised Systems Validation (CSV) in accordance with EU GMP Annex 11 requirements
Food Safety, HACCP & Quality Assurance Services
Food safety is non-negotiable. Let us help you stay compliant and in control.
Myloy Health provides professional food safety, HACCP and quality assurance services in Malta, helping food businesses establish, maintain and improve effective food safety and quality management systems. Our support can help businesses with HACCP implementation, food safety procedures, quality management systems, risk assessment, documentation and compliance support.
Whether you are establishing a food safety system, reviewing your existing HACCP documentation or looking to strengthen your quality processes, Myloy Health can provide practical, tailored support to help you maintain robust food safety and quality standards.
Our services include:
- HACCP system development and review
- Food safety procedures and documentation
- Food safety risk assessments
- Quality assurance and quality management support
- Review and improvement of existing food safety systems
- Compliance and documentation support
- Practical advice for maintaining effective food safety controls
Need support with HACCP, food safety or quality assurance in Malta? Contact us to discuss your requirements.
Food Supplement Regulatory Support
From formulation to market entry, let us help you get your food supplement compliance right.
Launching or reviewing a food supplement requires careful consideration of its product information, documentation, labelling, claims and packaging. Myloy Health provides practical food supplement regulatory support for EU and UK markets, helping businesses identify potential compliance issues and determine appropriate corrective actions.
We have experience with food supplement compliance assessments, label and artwork reviews, claims assessment, packaging and technical documentation review, food supplement notifications, import compliance and EU market-entry support.
We can also coordinate with manufacturers, laboratories and other stakeholders to help obtain and assess the information needed for the regulatory review.
Need help with a food supplement?
Learn more about our Food Supplement Regulatory Services
Cosmetics Regulatory Affairs
Keep your cosmetic products ready for the market with practical regulatory support.
Myloy Health supports businesses with the regulatory review of cosmetic products, documentation, labels, artwork, claims and packaging for EU and UK markets.
Our specialists have experience in cosmetic regulatory affairs and quality assurance, including formula and product documentation review, claims and packaging assessment, Cosmetic Product Notification Portal (CPNP) notifications, and coordination with manufacturers and internal teams.
Whether you are preparing a new cosmetic product, reviewing existing materials or getting ready for market entry, we can help identify potential regulatory issues and provide practical recommendations for corrective action.
Planning a cosmetic product launch or regulatory review?
Explore our Cosmetics Regulatory Compliance Services
Translations
We provide translation services for various languages such as: Maltese, French, Russian, Ukrainian, Belarusian, Kazakh and Moldovan.
Who Do We Help?
We work directly with:
- Regulatory Affairs Managers
- QPPVs and PV Associates
- Quality Assurance Teams
- QPs and RPs
- Company owners
- Business development personnel
- Pharma Startups & SMEs scaling to new markets
If you’re feeling overstretched or preparing for an inspection, we’re here to provide scalable, compliant, and cost-effective support.
Why Partner With Us?
- Global Regulatory Expertise – EU, MENA, LATAM, CIS, Asia-Pacific
- Fast, Flexible Service – Designed for growing teams under pressure
- Proven Track Record – Supporting generics, biologics, injectables, and OTC
- Collaborative Approach – We become part of your team
Ready to lighten your regulatory load?
Contact us today to learn how we can support your regulatory, pharmacovigilance, and GMP/GDP compliance needs.