Regulatory Affairs
Regulatory requirements play a crucial role in every stage of pharmaceutical product development and are established and overseen by Regulatory Agencies, governmental bodies operating at national or supranational levels. The Regulatory Affairs department ensures strict adherence to these requirements, responsible for securing approval for new products and maintaining it throughout their market presence.
Medical writing
Medical Writing is a vital activity across all stages of pharmaceutical product development. By crafting comprehensive and detailed documentation tailored to every aspect of the product, it helps define its characteristics and ensures compliance with regulatory requirements.
Pharmacovigilance
Pharmacovigilance plays a key role in ensuring the quality and safety of pharmacological treatments, involving a complex set of activities aimed at identifying, evaluating, monitoring, and preventing adverse reactions to drugs. Its main objective is to enhance the understanding of the risk-benefit profile of a drug, thereby contributing to the protection of patients’ health.
Clinical Trials
Good Clinical Practice (GCP) stands as a global benchmark for ethical and scientific quality in designing, documenting, and reporting studies involving human subjects. Adhering to this standard ensures the protection of the rights, safety, and well-being of study participants, along with the reliability of clinical data.
