ADE Evaluation/Drug Safety Assessment, Adverse Event Management/Software, Consulting, Electronic Submissions Preparation, Expert Reports, Medical Devices/Combination Products, Medical Writing, Pharmacovigilance, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy
Medical Science, Medical Affairs, Regulatory Affairs, Pharmacovigilance and Risk Management
Dr. Ebeling & Assoc. GmbH operates a flexible delivery model for PV and Regulatory Services enabling our customers to better manage their costs and associated resources. Managing product risks effectively is one of the biggest business challenges for the Health Care Industry and is essential to the success of an organization. We offer complete services for companies or work on individual project modules, either ad hoc or on an ongoing basis.
Qualified Person for Pharmacovigilance (QPPV) AND EU-Legal Representative
According to EU-law, the provision of a QPPV responsible for overall pharmacovigilance is mandatory for Market Authorization holders. Our QPPVs are fully experienced in all aspects and functions of EU-QPPV - like establishing, maintaining and overseeing the MAHs entire PV system and the safety profiles of the company’s products. Furthermore, we provide competent EU-legal representation services for non-EU-based Pharmaceutical Companies.
PV systems provide oversight of the MAH’s safety systems, processes and procedures and are eventually aiming at patient’s safety. Putting a company’s pharmacovigilance system into practice requires a systematic, practical and logical approach and Dr. Ebeling & Assoc. GmbH is well versed to put these mechanisms in place. This includes the preparation or validation of the PV System Master File – a legal requirement in the EU.
PSURs / ASRs (DSURs) / RMPs - REMSs
We manage compilation, review and submission of aggregate reports for regulatory authorities on your behalf. Dr. Ebeling & Assoc. GmbH has the special expertise in the preparation of PSURs/ASRs according to regulatory requirements. We can help you to avoid delay in product registration due to inadequate risk management. Dr. Ebeling & Assoc. GmbH has also experience in the preparation and evaluation of Risk Management Plans (RMPs) to comply with European Standards, as well as creating Risk Evaluation and Mitigation Strategies (REMSs) to satisfy US requirements.
Electronic Reporting (ICH E2B) and Electronic Submission (ICSRs / SUSARs)
Dr. Ebeling & Assoc. GmbH is able to support the full case management process. This service includes data entry, MedDRA coding, causality assessment and triaging, preparation of follow-up or nullification reports and expedited reporting to authorities. It entails the processing of ICSRs originating from various sources (e.g. spontaneous reports, literature reports, clinical trial reports, other sources). We carry out full quality control on each report and our trained staff has extensive experience in submission and receipt of ICSRs and SUSARs.
We operate a fully validated drug safety database which is E2B compliant and provides all the functionality required to meet your regulatory obligations and efficiency challenges. Dr. Ebeling & Assoc. GmbH can offer you an immediately available and cost effective system, removing the need for expensive installation and set-up of your own database in house. The safety data is hosted in a secure environment with appropriate back-up and disaster recovery programs in place.
Signal Detection Services
According to EU GVP guidance significant changes to the benefit-risk ratio of a product must be reported to the Competent Authorities. Dr. Ebeling & Assoc. GmbH is able to run and review data listings for your products, helping you with the assessment of the benefit-risk ratio or work out a signal detection process tailored to meet your needs.
Regulatory / Medical Affairs and Intelligence
If your company has ever tried to sell a new product or applied for Marketing Authorizations in international markets such as Europe, then you may have considered outsourcing. Entering a new market or navigating unfamiliar regulations may prove difficult, careful adherence to regulatory affairs is crucial. Dr. Ebeling & Assoc. GmbH knowledge covers all the regulatory elements required to obtain and maintain a Marketing Authorization.
CP / MRP / DCP / National Registration
Dr. Ebeling & Assoc. GmbH regulatory expertise comprises all areas of gaining EU product registration. There are four different pathways to apply for pharmaceutical product authorization in the EEA (European Economic Area): the Centralized Procedure, the Mutual Recognition Procedure, the Decentralized Procedure and the National Registration. Regulations are stringent and extensive documentation is required. It is imperative for any company to choose the right procedure and guidance for product registration and Dr. Ebeling & Assoc. GmbH provides support for all types of Marketing Authorization Applications, as well as the specific regulatory guidance.
Expert Reports / Dossier Compilation (CTD, eCTD)
Our experienced drug safety and medical writing personnel prepares the required documents on quality, safety and efficacy in the Common Technical Document (CTD) format for your registration dossier. If requested, we also convert the CTD into the eCTD format for you. Our staff is well trained with ICH, as well as region-specific guidance regarding the format and content of the CTD.