Vice President of Regulatory Affairs
Akhila has joined Pharma Science and Research Limited after spending the last 20 years working in the field of pharmaceutical regulatory affairs. Akhila’s work experience in the regulatory affairs field has spanned from the dossier submission process for both Active Pharmaceutical Ingredients (API) and Finished Dosage forms for numerous therapeutic segments.
Akhila specialises in two areas:
- The taking of newly developed or existing products through regulatory process to allow our clients to gain access to all major global markets including: Asia, Latin America, CIS, Middle East, South Africa, Canada, Australia, Turkey. Akhila has also performed extensive work across the European Union with major European regulatory agencies including the EMA, MHRA, BfArM, EDQM covering all licensing procedures and application types.
- The supporting of strategic regulatory activities impacting core business strategies (from identifying and targeting products to assist in increasing a client’s profitability and profile, to life cycle management and managing dossier submission of the API and Finished Dosage forms and the performance of GMP Audits on manufacturing facilities).