Parth Patel

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• Performed statistical analysis using tools - IBM SPSS and Prism Graph Pad • In vitro/ in vivo evaluation- Cell culture, microscopy, ELISA, bacterial culture, small-animal bio-imaging, handling of laboratory mice, inactivation, and working in the BSL-2 facility. • Formulation of Zika vaccine using the Spray drying methods • Formulation of buccal films- 3D dispensing • Formulation of microneedle patches - 3D dispensing • Formulation of Intranasla drops

• Promote the brand in the US and Europe. • Attend conventions, conferences, and one-on-one meetings. • Collaborate with internal teams—project management, business, and marketing—to execute plans, create promotional materials, and develop growth strategies. • Build and maintain strong relationships with existing and potential clients to understand their needs and ensure satisfaction. • Work closely with the CEO and senior leadership to align business development goals with overall company strategy. • Develop and maintain a comprehensive understanding of the pharmaceutical industry, regulatory environment, and CRO services. • Provide expertise in areas such as regulatory consulting, QA and independent audits, medical writing, project management, clinical monitoring (Bioequivalence studies and clinical trials), data management, clinical trials management (end-to-end or partial), and pharmacovigilance. • Manage Bioequivalence study monitoring, including visit scheduling and coordination between sponsors, CROs, and internal stakeholders. • Stay updated on regulatory guidelines relevant to existing clients. • Assist in developing and managing the business development budget. • Foster and manage client relations for both new and existing customers. • Develop proposals that address client needs, concerns, and objectives. • Handle multiple tasks efficiently, maintain control, and stay organized. • Implement business development strategies to expand the customer base and drive revenue growth. • Undertake any other activities assigned by management.

• Determine the most effective formation and dosage for a specific drug. • Responsible for developing various pharmaceutical products leading to successful NDA/ANDA filings and approval promptly through internal or external sources. • Responsible for handling multiple projects and prioritizing activities to meet milestones in a fast pace environment. • Responsible for reviewing literature and patents and working on the technical approaches for pharmaceutical/ ANDA product development. • Designing and conducting experiments for pre-formulation, formulation/process development, and scale-up for various drug dosage forms by following appropriate GMP regulations and safety requirements. • Responsible for execution of Registration batches and technology-transfer/ process development batches. • Responsible for preparation/review of product batch records and protocols for different product development stages, including R&D prototype formulation, scale-up to process validation by following related SOPs and procedures, ensuring the detailed description, and data-keeping. • Responsible for characterization of API, excipients, compatibility studies, conducting formulation trials, and compiling & review data to support successful development. • Supporting R&D function, selecting the proper equipment for various dosage form product development, developing SOPs and technical documents to support equipment's IQ/OQ/PQ processes. • Ensure all equipment is in good condition to promptly and effectively conduct product development experiments; maintain formulation Lab in a clean and safe working environment. • Write / record development work and draft technical reports to support product development, specifications, and stability in NDAs/ANDA and other regulatory submissions. • Ensuring all regulatory documents comply with SOPs, FDA Regulations & cGMP policy where applicable. • Maintaining compliance with GMP, SOPs & DEA regulations.

• Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, ICH-GCP, and regulatory requirements to ensure protection and ethical treatment of human subjects; applicable regulatory bodies like USFDA: 21 CFR 312, DCGI, MHRA, EMEA, and ANVISA • Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC • Perform monitoring activities per the monitoring plan (e.g., verification of source documents and CRFs, site communications, follow-up on data anomalies.) • Review the accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools) • Ensure accountability of Investigational Product (IP) and related supplies are performed when appropriate • Ensure complete reporting and proper documentation of monitoring activities; • Conduct routine monitoring visits (on-site or remotely) independently from the investigative site study staff • Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness • Training of study team regarding Protocol, Monitoring Plan, Update and maintenance of essential documents and for startup activities & Site Initiation activities, as applicable • Keep a close association with a site(s) for Patient recruitment, patient follow-up, and protocol-related activities; Conduct site visits as per the Clinical Management Plan • Coordinate in management of study drug/supply/equipment delivery, shipment, Inventory, and accountability; Responsible for receipt, storage, handling, control, supply, accountability, retrieval, and reconciliation of IP • Create, organize, and collate documents required by the project team before the start of the study; Collate and review essential records from study sites for Clinical study files • Coordinate and distribute Clinical Study Material to Study sites.

• Worked with the Quality Assurance team members to establish and maintain the company's quality systems, including coordinating with another department • To review All Documents • To supervise day-to-day workflow • To prepare and review QA SOPs and other department SOPs • Ensure facility compliance with regulations, best practices, and quality standards. • To issue the forms and logbooks to the concerned department • To prepare and update the audit plan • To review and audit the final report

• Handling a range of formulations from tablets/ capsules to Trans-dermal drug delivery dosage forms. • Process Validation Protocol (PVP), Process Validation Report (PVR), Master Batch Record (MBR), Master Labeling Record (MLR), and Master Packaging Record (MPR).

• Designed experiments for formulation optimization and characterization of the vaccine project • In the experiment, getting critical data for NIH grant applications and writing preliminary drafts (R21, R15). • Performed statistical analysis of the data collected using tools such as graph pad prism, interpretation of data to draw conclusive results, and communication of the critical outcomes of the study in departmental seminars and conferences.

A pharmaceutical company's regulatory affairs (RA) department is responsible for obtaining approval for new pharmaceutical products and ensuring that support is maintained for as long as the company wants to keep the effect on the market. • GMP, GLP, and GCP • Documentation of drug trials • QA and Drug regulations (depends on guidelines) • CTD format, eCTD format • Compliance guidelines, Govt. Audits FDA, MHRA, PMDA, TGA, DCG, and Breach reports.

Pharmaceutical Chemistry is one of the significant B.Pharmacy subjects and encompasses the study of the chemical and pharmacological aspects of drugs & such products. It includes different areas of study, such as the synthesis of pharmaceuticals, identification, analysis, and study of chemical characteristics.