de
enDr. Cölestin Allgäuer - Pharma Consulting - Services
PHARMACOVIGILANCE
Risk Assessment and Control of Elemental Impurities (ICH Q3D)
- We support pharmaceutical companies in implementing the Guideline for Elemental Impurities (ICH Q3D, step 5 from 25. July 2016). We identify, classify and quantify elemental impurities in a medicinal product and perform the risk assessment. Furthermore, we create a control strategy for a drug product that assures that elemental impurities do not exceed the PDEs and provide patients with the very best in safety. At your request we also support you in the monitoring and assessment of the effectiveness of risk minimisation measures.
Periodic Safety Update Report (PSUR)
- We prepare submittable PSURs for your medicinal products in line with the actual regulatory requirements (GVP Module VII, from December 2013). We evaluate your company-specific data on an individual basis and include the results of detailed research on adverse drug reactions in the scientific literature.
REGULATORY AFFAIRS
Marketing authorisation dossiers in CTD format
- We provide support for the subject of market access, elaborate the optimal strategy of marketing authorisation of pharmaceuticals and prepare the marketing authorisation dossiers in CTD format. We take over the preparation of the pharmacological/toxicological expert reports (Module 2.4, 2.6 und 4), clinical expert reports (Module 2.5, 2.7 und 5) and quality dossier (Module 2.3 und 3).
more information on marketing authorisation dossiers in CTD format
Assistance with deficiency letters
- We answer queries and deficiency letters from authorities or notified bodies, irrespective of whether we were originally involved as appraisers.
more information on regulatory affairs
HOMEOPATHICS
We take over the preparation of the pharmacological/toxicological expert reports and clinical expert reports in CTD format for the registration or authorization of homeopathic medicinal products.
more information on homeopathics
BACH FLOWER REMEDIES
- We prepare safety assessments for Bach flower remedies both with the legal status of a medicinal product by presentation and the status of food in accordance with the directive 2001/83 EC and the EC general food law regulation 178/2002, respectively.
more information on Bach flower remedies
MEDICAL DEVICES
- We provide support primarily for the registration of „substance-based“ medical devices in accordance with the actual regulatory requirements (Council Directive 93/42/EEC, Directive 2007/47/EC, MEDDEV 2.7.1, ISO 10993-1). We prepare reports on biological and clinical evaluation of medical devices to demonstrate that the device complies with the relevant essential requirements covering safety and performance.
more information on medical devices
COSMETICS
- We prepare cosmetic product safety reports (CPSR) for the cosmetic products of our clients in accordance with the relevant regulations, such as the German Cosmetics Ordinance (KVO) and the EU Cosmetics Directive (1223/2009).
LITERATURE RESEARCH
- We take over the literature search meeting the requirements set out in the GVP module VI including weekly literature search of the scientific and medical literature, retrieval of scientific medical publications with relevance to drug safety or benefit-risk-balance. In addition, at your request we also take over the identification of events, which fall within the definition of reportable valid ICSRs.