Liliana Teles
CEO / Regulatory Affairs & Quality Assurance Director
Regulatory affairs
Firm
We take on the legal role, not only the advice.
CRITICAL CATALYST is a technical consultancy based in Matosinhos, Portugal, founded in 2018. We work in regulatory affairs for cosmetic products in the EU, the UK and the US, for medical devices in the EU and Portugal, and in public health for Portuguese municipalities and health authorities.
What we stand for, in practice
Our mission is to help companies meet the legal requirements, standards and good practice that apply to them, and to make a clear path through regulatory complexity.
Three positions follow from it, and one limit.
We take on legal responsibility
Where the law requires a named person or company to answer for a product, we can take that role: EU Responsible Person for cosmetics, UK Responsible Person, outsourced Person Responsible for Regulatory Compliance (PRRC) for medical device manufacturers who may use one, and six other roles. With a legal role we take on obligations alongside you, not from the sidelines.
Regulatory by design
We work upstream. The requirements are set early, as specifications your team can design against, instead of being checked against a finished product.
A partner, not a documentation service
Documents are what we hand over. The work is the route: what applies, in what order, who is involved, and what can go wrong.
Not a laboratory
We do not run stability, microbiology, dermatological or efficacy tests. We coordinate external laboratories, and we tell you so when the question comes up.
How we work
Positions we hold in every engagement, including when they are inconvenient.
A sign-off is a conclusion
When a safety assessor signs a cosmetic product safety report, that is a professional conclusion. We do not approve a file and leave a recommendation to test further in a footnote.
Nothing we cannot confirm
A regulatory or quantitative claim we cannot confirm is flagged as such. We do not assert it.
Honest about deadlines
If the date you are working to is not realistic, for example because a stability test has a fixed window, we say so early.
Firm, with an alternative
When we hold a position you would rather we did not, we bring another path with it: parallel workstreams, a narrower test plan.
One view across regimes
Cosmetics, device, distribution and chemical rules often touch the same product. We read them together, not one at a time.
Independent means independent
A study commissioned by a supplier is not described as independent in material we prepare for distributors.
The people who do the work
You will know who handles your file.
PharmD; MSc (Pharmaceutical Sciences; Pharmaceutical Medicine); CCP (pedagogical competence certificate); ISO 9001 and ISO 13485 auditor; good distribution practice (GDP) specialist (TÜV Rheinland)
Leads regulatory affairs and quality assurance for medical devices and cosmetics: ISO 13485 quality systems, CE-marking roadmaps, EN ISO 14971 risk management, cosmetic product safety reports and claims. She is a co-founder of the firm and previously worked as a Regulatory Affairs Director.
Emanuel Valpaços
COO / Public Health & Medical Affairs Director
Public Health
MD (Faculty of Medicine, University of Porto, 2011); MSc Public Health (London School of Hygiene & Tropical Medicine, 2014); certified Public Health specialist (Public Health College of the Portuguese Medical Association)
Leads public health and medical affairs: public health strategy and programmes, project coordination, and the human-health chapter of environmental impact assessments. He is a co-founder of the firm, with more than ten years across medicine, community health and public health.
Beatriz Martinho
Epidemiology & Data Science Consultant
Public Health
MSc Clinical Bioinformatics (Clinical Decision Support), University of Aveiro; BSc Biology, University of Aveiro
Works on public health data analysis and descriptive epidemiology: municipal health profiles and strategies, health-indicator platforms in Power BI, and population health profiles for the human-health chapter of environmental impact assessments. She is part of the Epidemiology & Data Science area, which Emanuel Valpaços leads.
Guilherme Semedo
Medical Devices Regulatory Affairs Consultant
Medical Devices
MSc; PhD candidate researching AI, risk management and quality management of AI-enabled medical device software; trained ISO 13485 internal auditor; advanced training in ISO 14971 risk management
Works on qualification and classification under the Medical Devices Regulation, clinical evaluation literature research, risk management and technical documentation. He is part of the Medical Devices area, which Liliana Teles leads.
Mariana Pinto
Medical Devices Regulatory Affairs Consultant
Medical Devices
Pharmacist
Works on quality systems to ISO 13485, with more than 15 years in quality assurance and regulatory affairs at a manufacturer of non-active medical devices. She joined the Medical Devices area, which Liliana Teles leads, in November 2025.
Marta Pinto
Cosmetic Products Regulatory Affairs Manager
Cosmetic Products
Runs the day-to-day cosmetics practice: cosmetic product safety reports and product information files, notification, claims and label compliance. She is part of the Cosmetic Products area, which Liliana Teles leads.
Rodrigo Carvalho
AI Systems Engineer
AI Systems
MSc Computational Engineering (integrated master's), University of Aveiro
Works on AI and machine learning, including retrieval-augmented generation (RAG) and time series, and on data platform infrastructure: PostgreSQL and PostGIS, validated loading of official data and open-data publishing. He is part of the AI Systems area, which Emanuel Valpaços leads.
Three entities, one firm
The entity that signs your contract depends on the market. UK and US work is contracted locally.
Portugal and the EU
CRITICAL CATALYST - Health Consulting, Lda.
Av. Menéres 640 - Sala 247, 4450-189 Matosinhos, Portugal (operating HQ)
Every market not named below
United Kingdom
CRITICAL CATALYST LTD
35-37 Ludgate Hill, London EC4M 7JN, United Kingdom
UK clients; UK Responsible Person work
United States
CRITICAL CATALYST LLC
30 N Gould St Ste N, Sheridan, Wyoming 82801-6317, USA
US clients; US Agent work under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The UK and US companies are separate legal entities of CRITICAL CATALYST - Health Consulting, Lda. When we act as your UK Responsible Person or your US Agent, the contract is with the entity in that market.
Where to go next
- Cosmetic Products: safety, notification, the EU and UK Responsible Person and the US Agent
- Medical Devices: from qualification to post-market, in the EU and Portugal
- Public Health: municipal health strategy, human health in environmental impact assessment, health indicators and data
- Regulatory roles: the nine roles we take on
Tell us what you are working on.
The product, the market and the date you are working to. If the date is not realistic, we will say so.
Follow an area
One email when an area publishes, in the language you choose. Nothing else.
Talk to us
Tell us the product, the market and the date you are working to. If the date is not realistic, we will say so.
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