Regulatory Affairs Services
For Pharmaceutical products and medical devices
Nancy Falla
Too much regulatory work? Unsure about the regulatory strategy? Need external regulatory advice? Contact us…
Why choose us
Polyvalent experience at your service
Drug development
We can help preparing your clinical trial applications, your scientific advice documentation, orphan drug designations... We can coordinate preparation of answers to authorities and follow-up until approval. We can set up meetings with authorities, to validate your development program.
Marketing
Authorisation
We can help preparing your Marketing Authorisation Application dossier. We do have experience managing the all the parts of the dossier for the European Union and Switzerland (Administrative, quality, nonclinical, clinical). In addition, we do have experience with MAAs in emerging markets.
Life-cycle management
We can help preparing variations and renewals. We can submit the dossiers and coordinate the procedures with health authorities until they get approved.
Photo by Patrick Tomasso on Unsplash
Type of products
Knowledge of...
Recent projects managed
Medical device
Clinical trial application (first in man study) in Switzerland for a medical device class III. Regulatory strategy for this medical device up to market. Compliance check of the documentation versus standards and regulatory guidelines.
Pharmaceutical product
Determine the regulatory Target Product Profile. Develop the regulatory strategy. Clinical trial application (phase II) and subsequent CTA amendments. Training team members about regulatory affairs topics. Re-purposing of old pharmaceutical products or off-patent products for new indications or new pharmaceutical forms.
