REGULATORY AFFAIRS & LIFE CYCLE MANAGEMENT.

Evaluating the best regulatory strategy and taking the products successfully through the marketing authorization is our objective. ARAC offers the following services in the framework of national and European procedures:

Regulatory Strategy and Product development

• Regulatory advice in the early phase of product development
• Tailor-made regulatory concept based on current legal conditions
• Project Management in cooperation with all involved departments
• Pharmaceutical, Pre-clinical & Clinical Development
• Regulatory intelligence and monitoring of changes in legislation
• Consultation of regulatory authorities for scientific advice
• Ensuring regulatory compliance with updated guidelines and legislation

Marketing Authorisation Procedures

• Evaluate data and define the appropriate procedure and legal status of the product
• EU compliant preparation/compilation of dossiers as eCTD incl. submission via required portals
• Check and validation of eCTDs based on current specifications
• Submission and Management of national MA applications, MRPs and DCPs with Austria as RMS or CMS
• Procedural management
• Writing of Risk Management Plans (RMPs)
• Writing of (overall) summaries and overviews according to Module 2
• Support in local adaptation and translation processes
• Translation of SmPCs/PILs (German/English; English/German) and composing of UA-PILs
• Processing and answering deficiency letters of authorities and communication with authorities
• Coordination and communication with regulatory authorities and external partners
• Marketing authorisation holdership
• Artwork check
• Harmonisation of product information across multiple markets

Life Cycle Management

• Preparation and submission of annual reports and renewals
• Variation classification and submission
• Management of CMC variations and updates to Module 3
• PSUR submission
• Support in post-approval labelling and packaging adaptation

Promotional Materials

• Review and approval of promotional materials in accordance with national legislation
• Review of digital and social media content for promotional compliance
• Trainings concerning national legal basis of promotion

Rx to OTC Switch

• Evaluate national legal basis for OTC switch possibility
• Preparation of switch dossier including OTC switch report
• Management of authority queries and responses during assessment
• Evaluation of the impact of reclassification on reimbursement and pricing

SME Status Submission

• Collecting the documents for SME status application
• Submission of SME status application to EMA to decrease regulatory fees
• Support in SME status renewal and annual revalidation

Legalisation of Documents

• Support in supplying and legalization of official documents (e.g. CPPs)
• Liaison with health authorities, embassies, and consulates for legalization and apostille procedures (e.g. CPPs)
• Management of timelines to ensure availability of legalized documents for submission deadlines

To be able to give global support we cooperate with specialists in regulatory affairs and with B2B partners in other countries
(see also www.regulanet.com).