A move from Hannover, Germany to Richmond upon Thames, United Kingdom created the new inspiring environment that led to the decision to establish the new company SORAPEX Ltd. Founded by Beate Sonntag in 2012, SORAPEX Ltd. was successfully providing Professional Services for Global Regulatory Affairs Consulting, Training and Project Management. A move back to Hannover, Germany (early BREXIT) led to the business decision to dissolve the Limited Company in UK and to start and operate as Professional Freelancer (Freiberufler) in Germany. Except for the Location and the Business model, the services and concept have not changed. The name and domain for SORAPEX are further in use, the description “Regulatory Affairs Consultant for Pharmaceuticals” was complemented.
The idea for the company's name derives from APEX. Originally Latin, APEX is known in German, English, and French. It describes the localization of the labeling information in the top triangle of the Common Technical Document in Module 1.3.
The SmPC is the "ultimate" summary of the CTD.
Presenting the individual motivation of the founder and focusing the business on regulatory affairs, SORAPEX communicates the message of SOnntag - Regulator Affairs Pharmaceutical EXcellence.
The slogan "Always lead the label" is aiming to summarize the HIGH IMPORTANCE of labeling, especially the Summary of Product Characteristics (SmPC) in the context of the well-known phrase "always read the label" used during the promotion of a product:
The SmPC is the basis of information for health care professionals on how to use the medicinal product safely and effectively
The SmPC is the key labeling document for the establishment of the patient information leaflet informing patients about the correct use of the medicinal product.
The SmPC is one of the main documents in the public domain.
The SmPC is published in national compendia in the corresponding national language (e.g. Vidal, Arzneimittel-Kompendium and eMC).
The SmPC is the agreed position between the Marketing Authorization Holder and the Regulatory Authority.
The SmPC is the basis for any promotional message and is key to reimbursement.
Proper labeling of products regulated by the FDA is extremely crucial. Improper labeling could cost a company millions of dollars in litigation and bad publicity.