Sunanda Dhavala

Sunanda Dhavala E-mail:-Mobile: - CAREER OBJECTIVE: To grow with a leading organization that utilizes my abilities to the fullest extent possible, helping me realize and develop my potential and be a part of a team that scales great heights through continuous learning process and utmost dedication. PROFILE: Almost 2 years in Medical writing of qualitative experience in Clinical Research. PROFESSIONAL SUMMARY: ⮚ Profound understanding of clinical research methodology and regulations. ⮚ Proficient in preparation of protocols for various regulatory agencies like USFDA, EMEA, Health Canada, MOH Turkey etc. ⮚ Efficiently prepared protocols for all types of bioequivalence studies (like crossover, parallel, replicate, steady state studies etc.). ⮚ Sound knowledge in ICH, FDA, WHO, ICMR & CDSCO guidelines. PROFESSIONAL EXPERIENCE: Worked as a “Research Associate”, PK and Medical Writing Division of AXIS Clinicals Ltd, Miyapur, Hyderabad since March 2016 to Janaury 2018. Roles & Responsibilities: ⮚ Preparation, review and finalization of protocols according to regulatory and sponsor requirements. ⮚ Preparation, review of Informed Consent Forms (ICF), Protocol summaries and Sample analysis forms. ⮚ Handling and response of Regulatory queries. ⮚ Regular interaction with the Sponsor and Investigators while preparing Protocols. ⮚ Attending conference and meetings to gain awareness about the latest updates related to regulatory submissions. ⮚ Proactively participating in internal, external and Sponsor audits. ACADEMIC OVERVIEW: COURSE NAME OF THE INSTITUTE PERCENTAGE (%) M.Tech (2014) Pharmaceutical SASTRA University, Thanjavur 80.3 Page 1 of 4 Technology B.Pharmacy (2012) Gandhi institute of technology and Management (GITAM), Vishakhapatnam 83.4 Intermediate (2008) Sri Chaitanya Junior College, Vishakhapatnam 86.9 CBSE (2006) Vijnana Vihara, Gudilova 79.4 ACADEMIC PROJECTS: 1. “Preparation and evaluation of Glibenclamide microspheres” (Anti diabetic drug) during B.Pharmacy at GITAM University, Visakhapatnam. ABSTRACT: Glibenclamide is an oral Antidiabetic agent which is widely used in the management of non-insulin dependent diabetes mellitus (type II). Microspheres were prepared by cross linking method using calcium carbonate as cross linking agent and Na alginate as polymer. After preparation of microspheres they were dried and evaluated for drug entrapment efficiency, particle size, dissolution studies and disintegration test etc. 2. “Formulation, Characterization and In-Vitro Evaluation of 6-Azauridine Loaded Bovine Serum Albumin Nanoparticles” during M.Tech at SASTRA University, Thanjavur. (Paper accepted on April 10th 2015 for Journal of Nanopharmaceutics and Drug Delivery Vol. 2, 1–6, 2014) www.aspbs.com/jnd ABSTRACT: 6-Azauridine (AzUrd) a potent pyrimidine analogue widely used in the treatment of psoriasis, dengue, flavi-viruses, herpes viral infections and neoplastic diseases. In the present study, biocompatible and biodegradable AzUrd loaded BSA nanoparticles were successfully synthesized and demonstrated their prolonged antiproliferation activity on HeLa cell lines. Synthesized nanoparticles were characterized by particle size distribution, zeta potential, polydispersity index, FTIR, scanning electron microscopy and in-vitro release studies. The formulated AzUrd BSA nano particles exhibited a uniform spherical shape and possessed less an average 330 nm size. In vitro release behavior of the drug from BSA conjugate suggests that about 50% of the drug was released during first 3 hrs and 85% of the drug gets released after 12 hrs. 3. “Process parameters effecting granulation process and reduction of lump formation in fluidized bed granulator” during internship in Granules India ltd at Gagillapur (hyd). ABSTRACT: The objective is to reduce the lumps formation during granulation process in the fluidized bed granulator and to obtain the good granules right at first time. In this work we need to study different parameters affecting the granulation process and understand how they are going to influence the process. The optimization of process parameters is necessary for enhanced granulation process which includes spray rate, fluidization air, atomization pressure, drying rate etc. TRAININGS & INTERNSHIP: ● Industrial training at Aurobindo Pharmaceuticals, Pydibhemavaram (Srikakulam Dist., A.P) Duration: Jan 8 – Feb 8 2012 ● Industrial visit to Eisai Pharmaceuticals India Pvt. Ltd., Vishakhapatnam Page 2 of 4 ● Completed working as intern with Granules India.ltd at Gaggilapur unit (Hyd) in granulation process. (Operation Excellence dept) HANDS-ON EXPERIENCE: ● ● ● ● ● ● Tablet Compression & Coating Dissolution Apparatus UV Spectrophotometer HPLC Formulation and R&D dept M.S Excel and word ACHIEVEMENTS: ● Award of Annual Merit Scholarship’09 for Top Ranker for consistent 2 semesters from GITAM University. ● Participated National Science Olympiad and attained merit position ● Participated in AWARENESS PROGRAM ON “Quality Generic Drugs For An Affordable Health Care” organized by GITAM University. ● Participated in poster presentation organized by VIGNAN University in Electronic Drug Delivery System. KEY STRENGTHS: ● ● ● ● ● ● ● ● Good interpersonal, verbal and written communication skills. Willingness to learn. Ability to deal with people diplomatically and comprehensive problem solving abilities. Able to work independently but seek guidance when necessary, escalating issues as required. Shows commitment to and performs consistently high quality work. Effective time management in order to meet daily metrics or team objectives. Offers support and constructive feedback to project team members. Positive attitude towards life. EXTRACURRICULAR ACTIVITIES: ● NATIONAL SERVICE SCHEME (NSS) member in GITAM University ● Organized “CONVENTUS-2008” a multi-dimensional meet at GITAM University ● Organized International Conference on Biotechnology in Pharma &Food Industry (ICBPF) hosted by GITAM University ● Active member in International Society for Pharmaceutical Engineering (ISPE) PERSONAL DETAILS: Name : Sunanda Dhavala Page 3 of 4 Languages Known: English, Telugu, Hindi. Hobbies : Reading books and listening music Reference: Available upon request. Place: Visakhapatnam Page 4 of 4