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
• Consultation of regulatory authorities for scientific advice

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
• Translation of SmPCs/PILs (German/English; English/German) and composing of PILs
• Processing and answering deficiency letters of authorities and communication with authorities
• Liaison with competent authorities
• Marketing authorisation holdership
• Artwork check

Life Cycle Management

• Renewal submission
• Variation classification and submission
• PSUR submission

Promotional Materials

• Check of promotional materials
• 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
• 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

Legalisation of Documents

• Support in supplying and legalization of official documents (e.g. CPPs)

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).