Protected: raPHARM

Regulatory and Educational Management for Drug Registration

30 Miklošičeva Street, SI-1000 Ljubljana, Slovenia



raPHARM is a consultancy and training provider specialising in pharmaceutical and medical devices regulatory affairs.

The company is experienced in the fields of education, consulting and outsourcing, and improves communications between competent authorities and the industry.

Meeting the regulatory requirements of EU countries, Slovenia, and Croatia, as well as SSE countries, RaPHARM’s customisable consultation services manage EU-related drug and medical device registration projects to help ensure successful submission.

Consulting services for regulatory compliance of drug products

raPHARM provides regulatory affairs management to ensure drug products meet international regulatory requirements throughout their lifecycles. The company also performs outsourcing activities to help focus a product’s competitiveness.

The firm’s regulatory services supports marketing authorisation (MA) submissions by performing documentation compliance checks and quality of document reviews (QRD), assisting in good manufacturing practice (GMP) compliance, offering licencing support and optimising regulatory procedures. The company also provides expert opinions, overviews and dossier preparation.

Regulatory affairs services for medical device manufacturers

raPHARM offers professional regulatory support to medical device manufacturers, wholesalers and retailers, providing clients with regulatory compliance for registration submissions and classification issues.

The consulting services also help reduce time-to-market, ease post-marketing surveillance and support conformity assessment procedures. raPHARM is experienced in assisting companies in European Commission (EC) certification submissions and Declarations of Conformity.

In addition, the company develops standard operating procedures (SOP) for activities such as post-marketing surveillance and vigilance systems.

raPHARM also prepares technical documents and ensures the compliance of labelling and Instruction for Use (IoU) information, as well as performs risk assessments and risk management.

Regulatory intelligence services for medicinal and medical device products

raPHARM provides regulatory consulting services that combine efficient use of resources and in-depth analysis.

The company has deep knowledge of regulatory market conditions and requirements in countries such as Slovenia, Croatia, EU member states, Bosnia and Herzegovina, Macedonia, Montenegro and Serbia, which it utilises to plan submissions and other regulatory affairs activities.

Education and training for regulatory procedures

raPHARM organises regular seminars, training sessions and workshops designed to give an understanding of EU Acquis Communautaire and teach the very latest knowledge and skills necessary to manage regulatory procedures and projects.

The company offers courses and workshops led by experts at basic, refresher or advanced levels. The courses use case studies for a realistic and dynamic approach. The sessions are designed to provide an understanding of laws and by-laws specific to medicinal products and medical devices, taking care of national requirements.

The training courses can be customised to meet a client’s requirements, including a particular market or competent authority.

About raPHARM

Founded by Vensa Koblar, raPHARM has extensive experience working with EU institutions in the pharmaceutical and medical devices regulatory affairs sector, including European Commission (EC) committees, the EU Council working groups and the European Medicines Agency (EMA).

The company has also worked on projects with the World Health Organisation (WHO), the World Bank, Assistance Technique France (ADETEF), the British Standards Institution (BSI) and Technical Assistance and Information Exchange (TAIEX).

RaPHARM has successfully provided consultancy and regulatory services to more than 60 companies and organised more than 200 educational events, seminars, courses and workshops.

raPHARM, consulting and education, Ltd.

30 Miklošičeva Street

SI-1000 Ljubljana

Slovenia

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