regenold Portugal

Regulatory affairs, quality, pharmacovigilance, and market access expertise - built for the Portuguese market.

We are regenold's Portugal team: a locally founded consultancy, part of an international regulatory and development services group. Unlike traditional multinational models, we were built locally to address the specific needs of the Portuguese market, and only later integrated into an international group.

We combine deep, hands-on knowledge of the Portuguese regulatory and healthcare system with the tools and capabilities of a global organisation. We support companies operating in or entering Portugal, providing local expertise and flexible operational support across regulatory, quality, pharmacovigilance, and market access.

— Portugal Services —

What We Do Locally

Our Portugal team delivers these services through tailored local execution. For the full methodology, workstreams, and deliverables, see the central regenold service pages.

Regulatory affairs

National submissions, lifecycle management, scientific advice, interaction with INFARMED and support for market entry in Portugal.

Quality and compliance

Local quality oversight, GDP support, audit and inspection readiness, and compliance management.

Pharmacovigilance (PV) & Medical Information (MI)

Local PV contact, case management, local literature, regulatory compliance activities, and medical information services, including handling of local enquiries.

Market access

Pricing, reimbursement, and early access support, including dossier preparation, negotiation and interaction with INFARMED and national stakeholders, recognising that while evidence may be developed globally, successful access in Portugal depends on strong local expertise.

Flexible local expertise & outsourcing

Scalable local support across regulatory, quality, PV, and market access functions, delivered through a team-based model combining senior oversight, cross-functional expertise, and rapid integration into client systems.

— Key Local Capabilities —

Key Local Capabilities in Portugal

Flexible Local Expertise & Outsourcing

Support for companies with no or limited local presence, including hybrid and hub models, providing scalable expertise, senior oversight, and immediate operational capability.

Responsible Person (Technical Director) & WDL

Provision of qualified Responsible Person services and full support for WDL set-up and compliance, without the need for local hiring.

Local Pharmacovigilance (PV) & Medical Information (MI) Services

Provision of the legally required local PV contact in Portugal, supported by a robust, audit-ready and audit-tested PV system and full integration with global pharmacovigilance structures. Services include dedicated 24/7 safety contact channels and structured local medical information services with dedicated enquiry lines during business hours, in local language.

Local Regulatory Platforms (INFARMED)

Support in accessing and operating national systems (e.g., SMUH, SIATS, GPUB), ensuring compliant submissions, lifecycle management, and effective interaction with INFARMED.

Pricing, Reimbursement & Early Access (Market Access)

Support across pricing, reimbursement, and early access programmes, including interaction with INFARMED and key stakeholders and local adaptation of global strategies.

GxP Audit Services

Planning and execution of internal audits, supplier qualification, and multi-GxP audits (GMP, GDP, GVP), both locally and internationally, ensuring compliance and inspection readiness.

EU-GMP Certification via INFARMED

Strategic support for MAHs and third-country manufacturers in obtaining EU-GMP certification through Portugal - a credible and cost-efficient entry point - including strategy, submission, and on-site inspection support.

CPP Requests & Legalisation

Management of CPP requests and legalisation processes, supporting global registration and expansion strategies.

Promotional & Educational Materials Review

Review and validation of promotional and non-promotional risk minimisation materials, ensuring compliance with SmPC, RMP, and local regulatory requirements. Support includes submission and approval processes with INFARMED, as well as coordination of production and local implementation with trusted partners.

Need support in Portugal?

Tell us about your organization, local set-up, products, and current needs - we'll define how to move forward efficiently.

Contact us
— Why regenold Portugal —

What Distinguishes Our Portugal Practice

Local roots, global strength

Built as a Portuguese company with deep operational experience, enhanced by the capabilities of an international group.

Designed for real operating models

We support companies with no or limited local presence, including small affiliates, Iberian or centralised EU structures, as well as hybrid and transitional models. Through flexible, scalable outsourcing, we deliver immediate operational capability, cross-system expertise, and rapid integration.

Multi-system experience

We work across multiple companies and systems, including Veeva Vault, TrackWise, SAP, Argus, LMS platforms, and eCTD tools. This allows rapid onboarding and immediate productivity.

Integrated within an international network

Working closely with regenold teams in Germany, Ireland, the UK, and Switzerland, we combine strong local execution with access to broader expertise across regulatory, quality, clinical, and market access. Beyond our own offices, we leverage regulanet®, the international network we founded in 2001, providing access to independent regulatory, development, and market access specialists in more than 90 countries.

— About Us —

Part of regenold

regenold Portugal is part of regenold, an independent regulatory affairs and development services company founded in 1994, headquartered in Germany with offices in Portugal, the UK, Ireland, and Switzerland.