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Regulatory Affairs

RS & M Pharma Consulting and its services are dedicated to support you in all matters related to the steps before during and after obtaining a marketing authorisation licence for your medicinal products and also covers all further related subjects. We will start with compiling your registration dossiers in the CTD format and submit them in European MR-and DC-procedures to obtain marketing authorisations for your products. Moreover, we organise tests of readability of patient information leaflets and will compile renewal applications and variations for your existing product licenses.

Medical Affairs

We are able to support you with tasks covering pharmacovigilance issues and compilation of risk management plans, as well as management of safety data agreements. We write your "Investigational Medicinal Products Dossiers" (IMPDs) as well as clinical and non-clinical experts reports and we compile the product information texts (SmPC and package leaflet) for your medicines. Environmental risk assessments (ERAs) are part of our support as well.

Pharmaceutical Services

We provide support in all pharmaceutical areas that might be relevant to your product - already within the product development phase. We support you in the evaluation of suppliers of active pharmaceutical ingredients (APIs) and evaluation of professional contract manufacturers, as well as specialised laboratories for chemical and pharmaceutical product testing.
We take care of Quality Management issues and we compile your QA-handbook or revise it including compilation or update relevant Standard Operating Procedures (SOPs).

Business Development

We develop your individual company and licensing strategies closely with you and support your future plans and activities. We carry out due diligence projects and we evaluate your product portfolio.
Last but not least, we offer to support you on-site at your offices in close harmonisation with the affected colleagues.

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