Regulatory Services and Management Consulting for Pharma
Consulting company for pharma-regulatory issues and project management
in the healthcare industry
Regulatory Services and Management Consulting for Pharma (RS & M Pharma Consulting) is a service company founded by Ruth S. Moghtader, PhD, which has been successfully working for its clients in the areas of registration of medicinal products / regulatory affairs for more than 20 years.
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Prior to founding her own company, Ruth Moghtader obtained over 10 years of successful work experience during her employments in leading positions at small, middle-sized as well as internationally acting pharmaceutical companies. She provides you with a range of valuable work and leadership experience in the field of Regulatory Affairs and related areas of work.
In addition, RS & M Pharma Consulting advises you individually through a well-maintained network and through cooperation with specialized service providers from related fields and provides you with reliable and qualified support in achieving your company's goals.
Our services focus in particular on the following topics:
Regulatory Affairs
Regulatory Affairs
We support you in all matters relating to drug authorisations. You are welcome to entrust us with related tasks, such as the compilation of your registration dossiers in CTD format or applications for European MR and DC procedures.
Medical Affairs
We take on tasks covering pharmacovigilance issues and provide risk management plans. We also compile "Investigational Medicinal Products Dossiers" (IMPDs) as well as QRD-compliant product information leaflets and clinical and non-clinical expert reports.
Pharmaceutical Services
We support you in all pharmaceutical issues that may be relevant for your product – already within the product development phase. In addition to the selection of suitable active ingredient suppliers (APIs), this also includes the selection of professional contract manufacturers and specialized testing laboratories.
Business Development
Together with you, we further develop your individual company and licensing strategies for your products and are also happy to assist you with due diligence reviews and portfolio valuations.