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Regulatory affairs · Public health

Complexity,
made clear.

Regulatory affairs for cosmetic products in the EU, the UK and the US, and for medical devices in the EU and Portugal, including the legal roles those markets require. Public health work for Portuguese municipalities, health authorities and project developers.

Run the route

One instrument, three areas. A first map, not a regulatory conclusion.

Map your device's route to market

This is the route for a medical device sold in the EU and Portugal. To map your own, talk to us about your product.

EU

  1. Qualification and classification. Is it a medical device, and in which class? (Regulation (EU) 2017/745, Annex VIII)
  2. Regulatory strategy and roadmap. The class turned into a plan: the conformity route, how far a Notified Body is involved, and the milestones to market access. You get: a roadmap, and a gap analysis against the general safety and performance requirements (GSPR) that feeds your design inputs. (Regulation (EU) 2017/745 (MDR), Annex I)
  3. Evidence and technical documentation. Technical documentation under Annexes II and III, and the clinical evaluation. Inside the CE-marking programme: risk management, usability and, for an IVD, the IVD performance evaluation. (Regulation (EU) 2017/745, Annexes II and III, Annex XIV; EN ISO 14971; EN IEC 62366-1)
  4. Notified Body and CE marking. We prepare the submission and follow the Notified Body's questions through to CE marking. The Notified Body decides. (Regulation (EU) 2017/745 (MDR))
  5. Registration and distribution. EUDAMED actor registration, with the Single Registration Number (SRN). UDI and device registration support, and guidance on implementing unique device identification (UDI), including the design of the UDI carrier. (EUDAMED (EU))
  6. Post-market and outsourced roles. Post-market surveillance, vigilance, and the person responsible for regulatory compliance. (Regulation (EU) 2017/745, Article 15) We can act as outsourced PRRC; European Authorised Representative, as an extension of the PRRC service.

runs alongside: Quality management system. An ISO 13485 system, adapted from your documents or built from a gap analysis, and audited internally.

PT · If you are a manufacturer

  1. The EU route. Portugal is in the EU, so the EU route applies. (Regulation (EU) 2017/745)

PT · If you distribute or import devices in Portugal

  1. Medical-device wholesale distribution compliance. For distributors and importers in Portugal: wholesale distribution under Portaria n.º 256/2016. (Portaria n.º 256/2016; Decreto-Lei n.º 29/2024, Article 27) We can act as Technical Manager for medical-device distribution in Portugal.

A first map, not a regulatory conclusion. Our responsibility starts when you engage us.

Where will you sell?

This is the route for a cosmetic product sold in the EU. To map your markets, talk to us about your product.

EU

  1. Formula and testing. Formula checked against the Cosmetics Regulation; tests planned and coordinated with external laboratories. (Regulation (EC) No 1223/2009; ISO 11930; ISO 17516)
  2. Safety report and product file. Cosmetic Product Safety Report (CPSR) signed by a safety assessor, and the Product Information File (PIF). (Regulation (EC) No 1223/2009; Regulation (EU) 2023/1545; SCCS guidance) We can act as cosmetic safety assessor.
  3. Label, ingredients and claims. Label, INCI list and claims reviewed together. (Regulation (EC) No 1223/2009, Article 19(2); Regulation (EU) No 655/2013 (Claims Regulation); Commission Recommendation 2006/647/EC)
  4. EU Responsible Person and CPNP notification. We act as your EU Responsible Person and notify on the Cosmetic Products Notification Portal (CPNP). (Regulation (EC) No 1223/2009, Article 4) We can act as EU Responsible Person.
  5. After launch. Cosmetovigilance and serious undesirable effects, inside the EU Responsible Person service; regulatory monitoring on request. (Regulation (EC) No 1223/2009)

Alongside the route: Manufacturing quality. ISO 22716 for your production site. For sites that also export to the US, we tell you whether FDA cGMP applies to what you sell there.

Beyond the route. We cover Canada, China and Brazil; other markets on request.

A first map, not a regulatory conclusion. Our responsibility starts when you engage us.

What do you need to deliver?

Municipal health strategy

  1. Municipal Health Profile. Health indicators by parish, on an interactive digital platform, with its maintenance. The profile shows where the municipality starts, and where the differences between parishes lie.
  2. Strategy elaboration. Consultation with the people and organisations the strategy depends on, then the strategy itself: priority areas, axes and measurable objectives.
  3. Implementation support. Technical support and follow-up while the strategy is put into practice: an implementation guide, technical meetings and an annual progress report.
  4. Monitoring and evaluation platform. An interactive platform on the strategy's indicators: dashboards, alerts when an indicator moves away from its target, and automated reports. Maintained and updated.

A strategy the council can track

Health indicators and data

  1. Health indicators platform. An interactive platform on primary health care facilities, with health and demographic indicators for the area they serve.
  2. Data updates. Written procedures for updating the data, so the figures stay current.
  3. Maintenance. The platform kept available and maintained.
  4. Integration into the municipal data platform. The platform connected to the municipal data platform, so health sits beside the municipality's other data.

Data the council can open in a meeting

Human health in environmental impact assessment

  1. Scope. Which health determinants the project may affect, and which population groups the descriptor covers.
  2. Baseline. The health of the people living around the project before it starts.
  3. Impact assessment. The project's likely effects on their health, in construction and in operation.
  4. Mitigation and monitoring. Measures to avoid or reduce the effects, and the indicators that will show whether they work.

The human-health descriptor of the EIA

We send the route here, by email.

Talk to the team ↓

Briefings

What is changing in the rules, what it means for you, and who here handles it. In English and Portuguese.

One lane per area: the latest briefing, when it was published, who handles the area and the roles we hold in it.

Cosmetic Products

Area team

Marta Pinto, Cosmetic Products Regulatory Affairs Manager

Monitoring report

European Commission requests SCCS Opinion on the safety of Cyclamen Aldehyde

Ingredient: CYCLAMEN ALDEHYDE

Date of publication: 8 June 2026

The Scientific Committee on Consumer Safety (SCCS) has accepted a mandate to assess the safety of Cyclamen Aldehyde, following potential classification as a reproductive toxicant under the CLP Regulation.

Monitoring report

European Cosmetics Regulation – Updates on Cosmetic Ingredients  

Topic: NEW RESTRICTIONS ON COSMETIC INGREDIENTS

Date of publication: 13 January 2026

The European Commission published Commission Regulation (EU) 2026/78, which brings new restrictions on several cosmetic ingredients that were classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR).

Monitoring report

United Kingdom publishes Technical Report on the Classification and Labelling of Talc 

Ingredient: TALC

Date of publication: January 2026

The United Kingdom (UK) Health and Safety Executive (HSE) has published a technical report concluding that Talc does not warrant carcinogenicity classification, diverging from ECHA's Risk Assessment Committee (RAC) opinion supporting Category 1B classification.

Medical Devices

Area team

Guilherme Semedo and Mariana Pinto, Medical Devices Regulatory Affairs Consultants

EU

How to demonstrate equivalence under the MDR

Clinical data from an equivalent device can support your clinical evaluation, but the MDR sets a higher bar than the Directives did. The three characteristics, data access, and documentation.

Public sector · Portugal

For municipalities, health authorities and project developers.

Public Health

Area team

Emanuel Valpaços, COO / Public Health & Medical Affairs Director; Beatriz Martinho, Epidemiology & Data Science Consultant

Follow an area →

Areas of work

Regulatory affairs for medical devices and cosmetic products, and public health. Open a card for the scope.

Medical Devices

From qualification to EUDAMED, with the PRRC role.

Medical devices, in vitro diagnostics (IVD) and medical device software. The Route Finder above draws the EU and Portugal; UK and US are mapped with you.

See the scope

Qualification and classification

Quality management system (ISO 13485)

Technical documentation and clinical evaluation

IVD performance evaluation

Notified Body assessment

Outsourced PRRC and European Authorised Representative

EUDAMED registration and INFARMED notification (SIDM)

Go to Medical Devices

Cosmetic Products

Safety, notification and the legal role in each market: EU, UK and US.

For brands, manufacturers and importers of cosmetic products.

See the scope

Formula review and claims substantiation

Cosmetic Product Safety Report (CPSR), signed by a safety assessor

Product Information File (PIF) and labelling review

EU Responsible Person and notification on the Cosmetic Products Notification Portal (CPNP)

UK Responsible Person and notification on Submit Cosmetic Product Notification (SCPN)

US Agent, FDA facility registration and product listing under MoCRA (Modernization of Cosmetics Regulation Act of 2022)

Cosmetovigilance and regulatory monitoring

Go to Cosmetic Products

Public Health

Municipal health strategy, health in environmental impact assessment, indicator platforms.

For Portuguese municipalities, health authorities and project developers.

See the scope

Municipal Health Profile

Municipal health strategy: elaboration and implementation support

Monitoring and evaluation platform

Health indicators platform and data

Human-health descriptor in an environmental impact assessment

Go to Public Health

Where the law requires a responsible person, we can be that person

We take on legal responsibility for clients, not only advice. Nine roles across cosmetics and medical devices.

Cosmetic Products

EU Responsible Person

EU

UK Responsible Person

UK

US Agent (FDA)

US

Responsible Technician (Portugal)

PT

Cosmetic safety assessor

Medical Devices

Outsourced PRRC

EU

European Authorised Representative

EU

Outsourced quality assurance (QA) Director

Technical Manager, device distribution (Portugal)

PT

Portugal and the EU

CRITICAL CATALYST - Health Consulting, Lda., Matosinhos

United Kingdom

CRITICAL CATALYST LTD, London, contracts UK work

United States

CRITICAL CATALYST LLC, Sheridan, Wyoming, contracts US work

See the nine roles →

How we work

Five positions we hold in every engagement.

Regulatory by design.

We shape product decisions early, rather than only reviewing compliance at the end.

Honest about deadlines.

If the date you are working to is not realistic, we say so.

A sign-off is a conclusion.

When a safety assessor signs a cosmetic product safety report, that is a professional conclusion, not a recommendation to test further in a footnote.

Nothing we cannot confirm.

Claims that cannot be confirmed are never asserted.

Not a laboratory.

We coordinate external laboratories for testing, and say so.

Our public health work, in figures

Impact assessment

20+ impact assessment studies, national and international
6+ years of specialised health impact assessment experience
7+ sectors, from energy to tourism
Request a proposal

The people who do the work

You will know who handles your file.

Liliana Teles

CEO / Regulatory Affairs & Quality Assurance Director

Regulatory affairs

Emanuel Valpaços

COO / Public Health & Medical Affairs Director

Public Health

Marta Pinto

Cosmetic Products Regulatory Affairs Manager

Cosmetic Products

Guilherme Semedo

Medical Devices Regulatory Affairs Consultant

Medical Devices

Mariana Pinto

Medical Devices Regulatory Affairs Consultant

Medical Devices

Beatriz Martinho

Epidemiology & Data Science Consultant

Public Health

Next step

Follow an area, or tell us what you are working on.

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.

Talk about a product Request a proposal
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