Saporiti Consulting
Regulatory Affairs & Formulation Development
CONSULTING SERVICES
Design:
Starting from an accurate evaluation of specific clinical and commercial needs, we define features of the finished product and develop it.
Formulation development:
Choosing actives, excipients, pharmaceutical presentation and selecting organoleptic and sensorial properties are key features for clinical effectiveness and successful placing on the market of each product.
Labelling and communication:
A complex regulatory frame sets for each product a specific claims definition, compliant phrasing for labeling and advertising, according to laws requirements.
Regulatory and scientific assistance:
During product’s life, it might be needed to make notifications or variations, answer to Health Authorities enquiries, develop scientific technical dossier aimed to medical class information and material intended for communication to the end users.
Finished product:
Managing scale-up and production phases, choosing a producer, certifications, effectiveness and quality assessment are key point for launching an high quality product on the market.
