Pharma Regulatory Affairs Services

Explore our wide solutions portfolio

Services by Department

Scientific &Amp;Medical Writing Asphalion

Medical and Scientific Writing

Our Medical and Scientific Writing team provides you with support to build the foundations of strong non-clinical and clinical developments.

Medical Devices Asphalion

Medical Devices

Our team of Medical Device consultants, integrated together with our pharmaceutical and scientific consultancy services, will keep you ahead of market challenges and will help you meet all regulatory and quality requirements.

Data Management Asphalion

Data Management

Achieve efficiency by using the latest Data Governance and E-Tools:
ISO IDMP | Data Governance Services & RIMs Implementation | xEVMPD

Horizon Europe Eu-Funded Programmes

Horizon Europe EU-funded Programmes

Expert regulatory partner to ensure compliance with regulatory requirements of Horizon Europe EU-funded Programmes and with consortium objectives, maximizing requested benefit and impact.

Services by Stage of development

Preclinical Asphalion

Preclinical development stage

Early assessment of your product to ensure smarter and faster development plan and proper regulatory pathway in the pre-clinical development stage.

Clinical Development Asphalion

Clinical development stage

Product-specific regulatory support for optimal transfer from pre-clinical data to a clinical development stage to meet with regulatory requirements

Registration Asphalion

Registration

The correct Marketing Authorization application for a medicinal product, together with product particularities and complex regulatory requirements are key steps to be considered to ensure timely product commercialization in strategically defined markets.

Life Cycle Management - Asphalion

Life cycle management

Regulatory strategy and assistance through product life cycle post-approval to ensure compliance, safety and optimal product maintenance.

Services by Product

Medical Devices Asphalion

Medical Devices

Our team of Medical Device consultants, integrated together with our pharmaceutical and scientific consultancy services, will keep you ahead of market challenges and will help you meet all regulatory and quality requirements.

Biologicals Asphalion

Biologicals

Our expertise with Biologicals helps you succeed in the complex development and registration of this type of product

Atmps Asphalion

ATMPs

Offering end-to-end solutions for Advanced Therapy Medicinal Products (ATMPs).

Drugs Asphalion

Drugs

Expertise and full range of services for small molecules.

Services by Region

Europe Asphalion

Europe

Providing Vision and Experience to manage regulatory Submissions in Europe.

Eu-Local Asphalion

EU Local

Forget about the burdens: A robust management system of a strong network of partners to comply with local European regulations.

Spain Regulatory Asphalion

Spain

Our top leading history and experience in the Spanish market positions Asphalion as the best partner to ensure rapid commercial success.

Usa Asphalion

USA

Our expertise in expanding your market backed by our experience in the US.

Other Countries Asphalion

Other countries

Assessing the regulatory context of ROW countries together with local partners to ensure the smoothest marketing.