1. consulting and support in trading pharmaceutical products / medicines abroad (Middle East, Asia, Europe and USA) Salem-Pharma offers support to all customers in all phases of trading pharmaceutical products / medicines abroad (Middle East, Asia, Europe and USA). With diverse and in-depth experience, Salem-Pharma offers know-how and services related to the import / export of pharmaceutical / medical products and more. Supported by our offices in Switzerland, we work with clients worldwide to develop strategies to effectively address unmet medical needs in the pharmaceutical industry.
2. GVP Consulting - Qualified person responsible for pharmacovigilance Permanent pharmacovigilance is of utmost importance in all sectors and especially in the pharmaceutical industry. This is mainly due to the responsibility towards the patients, the changing regulatory requirements and the rapid changes in the industry. Only a professional pharmacovigilance system and intelligent quality management can ensure competitiveness. These ensure customer satisfaction and regulatory compliance as well as efficient operations. As a specialized consulting company, Salem-Pharma supports pharmaceutical companies in the pharmaceutical industry in these areas. Our clients benefit from ideal solutions that lead to a sustainable improvement of the pharmacovigilance system thanks to our profound industry-specific know-how. We analyze the current situation of each company in order to offer a perfect individual solution.
3. Qualified person / responsible person We assume the responsibility of a qualified person in accordance with the requirements of the Swiss Pharmacovigilance Ordinance to obtain or continue the operating license. In this capacity: Perform the function of a qualified person / responsible person on a permanent or temporary basis Employ direct supervision of facilities and implement regulatory requirements Make product release decisions Prepare for Swissmedic inspections, internal and external audits.
4. Ensure supplier and customer qualification Pharma Vendor Management Selecting the right vendor is critical for young companies. Choosing the wrong vendor can be detrimental to the program and lead to delays and cost overruns. In order to select the right vendor, it is critical that a formal selection process be conducted. It is important for the sponsor to explain all requirements and considerations to the vendor and address some of the key considerations such as assessment of core capabilities evaluation of project scope including details such as manufacturing scope, testing requirements, specification of product, packaging and labeling analysis of market trends budget and timelines for deliverables