Dr. Cölestin Allgäuer - Pharma Consulting - Services
- We support pharmaceutical companies in creating and implementing effective pharmacovigilance Risk Management Plans (RMPs) according to GVP Module V (Risk management systems). We identify potential risks associated with a medicinal product and create the risk management plan that will keep these risks at a minimum 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.
- We prepare submittable PSURs for your medicinal products in line with the actual regulatory requirements (GVP Module VII). 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.
- In addition we prepare further safety reports such as DSUR, ASR (EU), IND AR (USA), and PADER.
- At your request we take responsibility for the entire case report management process, including the evaluation of cases and the notification of the authorities. We prepare ADR reporting documents (ICSR) and submit them electronically to the corresponding authorities.
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).
Assistance with deficiency letters
- We answer queries and deficiency letters from authorities or notified bodies, irrespective of whether we were originally involved as appraisers.
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.
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.
- 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.
- 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).
- 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.