Regulatory Affairs

As a Regulatory Affairs consultant, I offer expert assistance to clients with all regulatory aspects related to the submission of clinical studies, from Phase I through Phase III (Pivotal), as well as Non-Interventional studies and management of the CT from study start up through close-out of the study globally (Feasibility, Site Selection, Site Identification, Clinical Operations Management (CRA, CPM, BioStatisticals, Data Management, GCP Audits..etc).

My expertise includes the Regulatory approval process (MAA) for a wide range of products: Medicinal Products

(including OTCs, Generics), Biological Medicinal Products (Advanced Therapy Medicinal Products (ATMP), and Biosimilar products), Paediatric Medicines and Orphan Drugs, Veterinary Medicinal Products, and Nutraceuticals, Medical Devices, Cosmetics, Products for Self-care, Biocides. Additionally, I provide specialized guidance in navigating the regulatory requirements for Herbal Products and Homeopathic Products, ensuring that clients meet both local and international regulations. Each client receives tailored support and strategic advice, helping them successfully navigate the complex regulatory landscapes.

I also assist in developing comprehensive regulatory strategies and provide detailed Roadmaps to guide the process of regulatory approval. This includes strategic planning and precise execution, all while ensuring compliance with relevant local and international regulations and guidelines, such as ICH-GCP, EMA, FDA, and others. Whether your company is seeking approval for a new drug, medical device, or alternative healthcare product, I provide the expertise needed to navigate through complex regulatory environments, ensuring timely and successful product approval.

With years of experience in regulatory affairs, I help my clients maintain compliance, mitigate risks, and ensure that their products are market-ready. By providing clear regulatory strategies and facilitating communication with regulatory bodies, I support the timely launch of products in compliance with global standards.”