Protected: raPHARM

Training and Consultation Services for Medical Device Regulatory Affairs

30 Miklošičeva Street, SI-1000 Ljubljana, Slovenia



raPHARM is a training provider and consultancy firm that improves communication between medical device manufacturers and regulatory agencies.

Specialising in medical devices and pharmaceutical regulatory affairs, the company focuses on education, consulting and outsourcing to speed the time-to-market for medical devices. Its regulatory experts provide customised guidance for the registration of pharmaceuticals and medical devices in EU countries, Slovenia, Croatia and SSE countries.

Consulting services for regulatory compliance of medical devices

raPHARM provides dedicated regulatory consultancy services to medical device manufacturers, wholesalers and retailers. It helps ensure that clients’ products meet regulatory requirements for registration, while also addressing classification issues.

The firm’s consulting services also help reduce time-to-market, support conformity assessment procedures and ease post-marketing surveillance. It has successfully assisted a large number of companies with European Commission (EC) certification submissions and Declarations of Conformity, as well as developed standard operating procedures (SOP) for the management of post-marketing surveillance and vigilance systems.

In addition, raPHARM assesses the compliance of labels and instructions for Use (IoU), creates technical documents and conducts risk assessments.

Regulatory affairs services for drug developers

raPHARM’s regulatory affairs services combine efficient use of resources and in-depth market analysis to help drug developers ensure pharmaceutical products meet the stringent regulatory requirements of countries throughout Europe.

Managing compliance throughout a drug’s complete lifecycle, raPHARM’s team of experts performs documentation compliance checks and quality of document reviews (QRD) to support marketing authorisation (MA) submissions. The company also helps clients meet good manufacturing practice (GMP) standards, supports licencing applications and optimises regulatory procedures.

Training programmes to develop regulatory procedures

raPHARM provides a wide range of training, workshops and seminars to offer a broad understanding of EU Acquis Communautaire laws. The courses teach the latest knowledge and skills necessary to manage regulatory procedures and projects.

Led by regulatory experts, the workshops are available in beginner, refresher or advanced levels, providing high levels of flexibility. They can also be customised to meet a client’s requirements to focus on a particular market of competent authority.

About raPHARM

raPHARM has worked with EU regulatory bodies in the pharmaceutical and medical device industries, including EC committees, the EU Council working groups and the European Medicines Agency (EMA).

raPHARM has also worked on projects for organisations such as World Health Organisation (WHO), the World Bank, Assistance Technique France (ADETEF), the British Standards Institution (BSI) and Technical Assistance and Information Exchange (TAIEX).

The company has extensive knowledge of regulatory market conditions and requirements in countries such as Slovenia, Croatia, EU member states, Bosnia and Herzegovina, Macedonia, Montenegro and Serbia.

raPHARM, consulting and education, Ltd.

30 Miklošičeva Street

SI-1000 Ljubljana

Slovenia

+386 1 438 16 00 www.rapharm.eu/en