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The candidate has 4 years of experience in the pharmaceutical industry, with 2.5 years in international regulatory affairs and 1.5 years in research and development. Their regulatory experience includes compiling and submitting drug master files and dossiers to various global health authorities. They are also experienced in analytical method development, validation, and technology transfer projects.
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R.D.PRABHAKARA REDDY is seeking assignments in pharmaceuticals with over 16 years of experience in quality assurance for APIs. He currently works as Assistant General Manager of Quality Assurance at Srikar Laboratories Pvt Ltd. He has strong understanding of GMP guidelines and experience handling inspections from regulatory bodies like US FDA, UK MHRA, and Australian TGA. He is experienced in supplier audits, compiling dossiers, and ensuring compliance with global regulatory requirements for markets like US, EU, Japan and Canada.
Regulatory aspects for registration of API in formulation
The document discusses regulatory aspects for registration of active pharmaceutical ingredients (APIs) in the United States and European Union. It provides definitions of Drug Master Files (DMFs) in the US and European Drug Master Files (EDMFs) in the EU. It describes the regulatory authorities, types of submissions, requirements, formats, languages, and websites for DMFs in the US and EDMFs/Certificate of Suitability (CEP) and Active Substance Master Files (ASMFs) in the EU. Submissions include confidential information about the API, manufacturing, and quality. DMFs support new drug and abbreviated new drug applications. EDMFs allow protection of intellectual property while allowing applicants to take responsibility for drug products
Dmf seminar
A Drug Master File (DMF) is a submission to the FDA that provides confidential detailed information about facilities, processes, or materials used in manufacturing drugs. There are 5 types of DMFs that cover manufacturing sites, drug substances and products, packaging materials, excipients, and other reference information. A DMF holder must authorize other applicants to reference their DMF and notify them of any changes. The DMF includes manufacturing and quality control procedures, validation data, and stability testing results.
Dmf & distribution records seminor
Drug Master Files (DMFs) provide confidential information to support drug applications and are submitted voluntarily to the FDA. There are 5 types of DMFs covering manufacturing sites (Type I), drug substances and products (Type II), packaging materials (Type III), excipients (Type IV), and reference information (Type V). DMFs require authorization letters for reference and annual updates to remain open. Distribution records must allow tracing batches and facilitate recalls, with requirements for storage conditions, oldest stock distribution, and records of further distribution by consignees.
Quality regulation for biological products current and future
The document discusses current and future regulation of biological products by the Korea Food and Drug Administration (KFDA). It provides an overview of the KFDA's functions in regulating biological product quality, registration processes, relevant laws and guidelines. It also discusses specific areas like viral product control and challenges in regulating this emerging field.
thiru_30_may_16
Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
Regulatory requirements for API and Biologics
The document discusses regulatory requirements for active pharmaceutical ingredients (APIs) and biologics. It provides an overview of regulatory guidelines for APIs, including requirements for registration of APIs with agencies like the FDA. It also describes regulatory filings like Drug Master Files (DMFs) that are submitted to provide confidential manufacturing information to support applications. Requirements for biologics are also briefly covered, noting they are complex molecules produced through biotechnology.
Submitting electronic Drug Master Files (DMF) and Active Substance Master Fil...
1) The document discusses submitting electronic DMF/ASMF dossiers to regulatory agencies in the US, Canada, EU, and Switzerland. It defines DMF/ASMF and describes the different types used across regions.
2) Key differences in DMF types and structures between regions are explained, including the division of dossiers into open/applicants parts and closed/restricted parts. CTD sections to be included in each part are provided for examples.
3) Conversion timelines and requirements for electronic submission formats like eCTD are outlined for each region. Canada and EU now require eCTD format for new submissions, while FDA accepts both eCTD and paper.
CV_AN
Narender Adepu is seeking a challenging position in quality with over 14 years of experience in the pharmaceutical industry. He holds an M.Sc. in Chemistry and has worked in quality control roles at various pharmaceutical companies. His responsibilities have included ensuring compliance with ICH, USFDA, and EU guidelines; method validations; stability studies; and handling audits. He is proficient in various laboratory software and analytical instruments and seeks to advance his career as a quality auditor.
CV_AN
Narender Adepu is a highly qualified and experienced Quality professional seeking a manager position in Quality. He has over 14 years of experience in Quality for API and pharmaceutical manufacturing. He holds an M.Sc. in Chemistry and has worked for several major pharmaceutical companies in various Quality roles, managing laboratories and leading audits. His technical skills include proficiency with GMP/GLP systems and analytical instrumentation.
DMF by Anthony Crasto
This document provides an overview of Drug Master Files (DMFs), including:
- DMFs allow companies to provide confidential manufacturing information to regulatory agencies to support drug applications without publicly disclosing sensitive details.
- DMFs are "closed" in the US, meaning only the regulatory agency reviews the file. In Europe, DMFs have both open and closed portions.
- The document outlines the key differences between the US and European DMF systems, as well as providing details on the types of information included in a DMF and the processes for submitting and reviewing DMFs with regulatory agencies.
CV - David O'Halloran Long Version
David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.
generic product development.pptx
This document discusses the process of generic drug product development. It explains that a generic drug is identical to the branded reference drug in terms of active ingredients, dosage form, safety and efficacy. The document then outlines several key steps in generic drug development, including selecting a product, ensuring API availability, developing analytical methods, conducting formulation development studies, manufacturing exhibit batches, conducting bioequivalence studies, and seeking regulatory approval from agencies like the FDA. It also discusses provisions of the Hatch-Waxman Act that aim to facilitate generic drug approval while compensating branded manufacturers.
ANDA regulatory approval process
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
Clinical evaluation and the latest 2016 guideline
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
Similar to Summary (20)
Regulatory aspects for registration of API in formulation
Regulatory aspects for registration of API in formulation
Quality regulation for biological products current and future
Quality regulation for biological products current and future
Submitting electronic Drug Master Files (DMF) and Active Substance Master Fil...
Submitting electronic Drug Master Files (DMF) and Active Substance Master Fil...
Summary
- 1. 4 years of Pharmaceutical industry experience with 2.5 years of International Regulatory Affairs and 1.5 years of R&D. International Regulatory Affairs Currently working in API regulatory affairs department. Responsible for compilation and submission of DMF’s/amendments with the USFDA, TPD Canada, EU authorities, KFDA, TGA, PMDA and various RoW health authorities. Submission of new application and revision dossier for CEP with the EDQM. Responding queries received from the USFDA, TPD Canada, EDQM and from various customers. Experience in handling regulatory requirements through the product life cycle both in preapproval as well as post approval phases with core focus in CMC. Review of various DMFs compiled by team members. Review of change proposals and TECHNOLOGY transfer documents for any regulatory implication. Preparation of Applicants part, Technical information files and issuance of various regulatory documents to the customers for ANDA fillings. Co-ordination with QC/ QA / R&D to collect the data for DMF’s compilation. Research and Development Past experience in research and development laboratory. Responsible for analytical method development in HPLC for monitoring the reactions, estimation of Assay, Related substances, Genotoxic impurities and chiral purity. Validation of methods as per ICH guidelines. Was part of technology transfer projects within R&D and manufacturing locations. Skills : Excellent communication, inter personal, team management and project management skills woven with a strong technical and functional background. Specialties : CMC Regulatory Affairs, CTD filling (Paper filling), eCTD filling (electronic submission), Devising Regulatory Strategies, Document Management System and Regulatory Strategy and analytical problem solving.