Arti is a key member of the regulatory team that is focused on medicines with 5+ years’ experience in the pharmaceutical industry. Arti has strong experience of working with the EMA and EU national regulatory authorities to gain new drug registrations and approvals for a wide range of changes to licences during the product lifecycle. Clients value her excellent communication skills.
Value to clients
Underpinned by roles working on branded medicines in ‘big pharma’ to generic medicines in small and large multinational organisations, Arti has a record of delivering fast licence approvals ahead of schedule.
- In-depth knowledge of generic medicines and their successful registration
- Mitigates regulatory risks to deliver high quality results
- Experienced in CTA’s, MAA’s, post-authorisation measures and post-approval activities
- Deep knowledge of regulatory, commercial, end user aspects of product information and packaging design and implementation.
After completing her pharmaceutical studies, Arti worked at B&S Group as an Account Manager where she built her knowledge on packaging and design of medicinal products. Arti then transitioned to a Regulatory Affairs Executive licencing and maintaining the company’s products. In this role she was able to apply her expertise to create packaging to meet the requirements of the end user whilst ensuring regulatory compliance. Arti moved on to gain experience in regulatory applications for generics (oral solutions) then latterly with complex respiratory products (dry powder inhalers and metered dose inhalers) at Teva.
Other things about Arti
- Experienced in Quality Management Systems
- Skilled in parallel import licencing and maintenance
- Fluent in Gujarati.