Praneeth Patnala

About Praneeth Patnala

At Techsol Life Sciences, our team ensures stringent adherence to diverse health…

Experience

1. Regulatory Officer

   Techsol Life Sciences

   Jun 2022 — Present · Hyderabad, IN

   Responsible to conduct the gap analysis according to Health Authority regulations and ensuring the compliance of all national and international regulations (FDA, EMEA, TGA and PMDA etc.)•Responsible to ensure that product labels conform to all applicable local, national, and international regulations and standards, such as FDA regulations in the United States, EMA regulations in Europe, or other relevant authorities in different regions.•Review and assess labelling content, including package inserts, prescribing information, and patientinformation leaflets (PILs).•Confirm that the labelling accurately reflects the clinical data, safety information, and approvedindications for the drug.•Prepare and submit labelling variations or updates to regulatory authorities as required.•Communicate with regulatory agencies to resolve labelling-related queries and provide responses in atimely manner.•Responsible to provide guidance and training to internal teams on regulatory requirements and bestpractices for drug labelling.•Preparation, Review and Submission of product registrations, import license applications and loanmanufacturing license application Dossiers for Medical Devices (Fresh filings, Re-Registration, QueryResponses) as per the Guidelines and as per the Timelines given to obtain marketing authorization.•Preparation and submission of CIP (Clinical; Investigational Plans), NDA, ANDA, IND and CTAapplications dossiers to local regulatory authority.•Review and create product labels and review promotional material for compliance with applicableregulations and technical standards.•Support external regulatory agency audits, providing regulatory input to minimize potential for findingsof non-compliance.•Work closely with cross-functional team members in quality, clinical and R&D as required on premarketand post-market projects to write submissions as well as resolve regulatory agency questions.

Education

• Giet School of Pharmacy

  Bachelor of Pharmacy - BPharm

  2013 — 2017