alexa
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)
 
 
 
 
 

Editorial Board

Recommended Conferences

Submit Manuscript

Journal Impact Factor 0.7*
Submit manuscript at http://www.editorialmanager.com/pharma or send as an e-mail attachment to the Editorial Office at regulatoryaffairs@pharmajournals.org

About the Journal

A set of norms, standards, and code of conduct govern the pharmaceutical industries across the globe to ensure a safe and secured healthcare system to all. These laws are varying from country to country. The dynamics in the regulatory affairs demands constant research, as the pharmaceutical industry should have to comply with the changes in technology, market and legal aspects in order to survive in the competitive markets.

Pharmaceutical Regulatory Affairs Journal is at higher echelons that enhance the intelligence and information dissemination on topics closely related to Regulatory Affairs. They provide a unique forum dedicated to scientists to express their research articles, review articles, case reports and short communications on an array of Pharmaceutical research. The Pharmaceutical Regulatory Affairs Peer Reviewed Journal is proficiently supported by universally prominent Editorial Board members. Pharmaceutical Regulatory Affairs journal impact factor is mainly calculated based on the number of articles that undergo a single blind peer review process by competent Editorial Board so as to ensure excellence, essence of the work and number of citations received for the same published articles. Abstracts and full texts of all articles published by Pharmaceutical Regulatory Affairs Open Access Journals are freely accessible to everyone immediately after publication.
Pharmaceutical Regulatory Affairs: Open Access (PRAO) is academic journal that includes a wide range of fields in its discipline such as technological, legal, ethical and market oriented information from across the globe to create a platform for the authors to make their contributions towards the scholarly journals  and the editorial office promises a peer-review process for the submitted manuscripts to ensure the quality of publishing.
This scholarly Open Access journal is using Editorial Manager System for quality in review process. Editorial Manager is an online manuscript submission, review and tracking systems. Review processing is performed by the editorial board members of  Pharmaceutical Regulatory Affairs Journal or outside experts; at least two independent reviewers approval followed by editor approval is required for acceptance of any citable manuscript. Authors may submit manuscripts and track the progress through the system, until publication. Reviewers can download manuscripts and submit their opinions to the editor. Editors can manage the whole submission/review/revise/publish process.

OMICS International through its Open Access Initiative is committed to make genuine and reliable contributions to the scientific community. OMICS International hosts over 700 leading-edge peer reviewed Open Access Journals and organizes over 1000 International Conferences annually all over the world. OMICS International journals have over 10 million readers and the fame and success of the same can be attributed to the strong editorial board which contains over 50000 eminent personalities that ensure a rapid, quality and quick review process. OMICS International signed an agreement with more than 1000 International Societies to make healthcare information Open Access. OMICS International Conferences make the perfect platform for global networking as it brings together renowned speakers and scientists across the globe to a most exciting and memorable scientific event filled with much enlightening interactive sessions, world class exhibitions and poster presentations.

 

Regulatory affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc.

Related Journals of Regulatory affairs

Journal of Molecular Pharmaceutics & Organic Process Research, Journal of Pharmaceutics & Drug Delivery Research, Journal of Pharmaceutics and Nanotechnology, Clinical Pharmacology & BiopharmaceuticsRegulatory Affairs, Clinical Research and Regulatory Affairs, International Journal of Drug Regulatory Affairs, Applied Clinical Research, Clinical Trials and Regulatory Affairs, International Journal of Drug Regulatory Affairs [IJDRA]

Quality assurance in regulatory affairs

Quality assurance (QA) is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled".

Related Journals of Quality assurance in regulatory affairs

Journal of Pharmaceutical Quality Assurance, Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutics & Drug Delivery Research, Journal of Pharmaceutical Sciences & Emerging DrugsAssurancePharmaceutical Quality Control, International Journal of Drug Regulatory Affairs, International Journal of Advanced Research in Pharmaceutical & Bio Sciences, International Journal of Quality & Reliability Management, International Journal of Pharmaceutical and Medicinal Research (IJPMR), International Journal of Pharmaceutical Sciences Review and Research, Regulatory Affairs Professionals Society (RAPS), International Journal of Pharmaceutical Sciences and Research, International Journal of Pharma Research & Review (IJPRR), International Journal of Pharmaceutical Investigation.

Regulatory affairs for clinical trails

The most important areas of regulations and guidelines controlling clinical trials will be covered including: understanding the importance of the EU Clinical Trial Directive; clinical trial authorisations; the increasingly important requirements for running trials in children; requirements for managing investigational medicinal product; legal aspects of clinical trials; pharmacovigilance; data management, GCP requirements; regulatory inspection and more. Topics will also include an update on the latest CT Directive guidelines and other EU Clinical Trial developments.

Related Journals of Regulatory affairs for clinical trails

Journal of Clinical Trials, Journal of Pharmaceutics & Drug Delivery Research, Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutical Sciences & Emerging Drugs, Clinical Research and Regulatory Affairs, Applied Clinical Research, Clinical Trials and Regulatory Affairs, International Journal of Drug Regulatory Affairs, Applied Clinical Research, Clinical Research and Regulatory Affairs

 

Regulatory requirements of pharmaceutical products

Regulatory requirements of pharmaceutical products deals with overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information.

Related Journals of  Regulatory requirements of pharmaceutical products

Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutics & Drug Delivery Research, Journal of pharmacy and pharmaceutical sciences, Journal of Molecular Pharmaceutics & Organic Process Research, International Journal of Drug Regulatory Affairs, Clinical Research and Regulatory Affairs, International Journal of Drug Regulatory Affairs, International Journal of Pharma Research & Review (IJPRR)

Pharmaceutical ethics

Pharmaceutical Ethics are formulated by Pharmacy Council of India which are meant to guide the pharmacist as to how he should conduct himself (or herself), in relation to himself (or herself), his / her patrons (owner of the pharmacy), general public, co-professionals etc and patients.

Related Journals of Pharmaceutical ethics

Journal of Clinical Research & Bioethics, International Journal of Applied Biology & Pharmaceutical Technology, Journal of Pharmaceutics & Drug Delivery Research, Journal of pharmacy and pharmaceutical sciences, Pharmaceutical Ethics, The Journal of Law, Medicine & Ethics, Journal of Medical Ethics, Saudi Pharmaceutical Journal, European Journal of Pharmaceutical Sciences, Ethics & Medicine

Anvisa regulatory guidelines

ANVISA means "Agencia nacional de Vigilancia Sanitaria" which is a regulatory body of Brazil. Brazil is the biggest country of South America. Some of the small countries nearby Brazil are following the rules according to ANVISA.

Related Journals of Anvisa regulatory guidelines

Intellectual Property Rights: Open Access, Journal of Pharmaceutics & Drug Delivery Research, Journal of Pharmaceutical Care & Health Systems, Journal of Applied PharmacyU.S. Regulatory Affairs, Journal of Pharma Research, International Journal of Research in Pharmacy and Science, Journal of Drug Delivery & Therapeutics, International Journal of Research in Pharmaceutical and Nano Sciences, Brazilian Journal of Pharmaceutical Sciences, Asian Journal of Pharmaceutical Technology and Innovation

British regulatory guidelines

The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). These include the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA now also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.These include the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA now also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.

Related Journals of British regulatory guidelines

Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutics and Nanotechnology, Journal of Pharmaceutics & Drug Delivery Research, Journal of Pharmaceutical Sciences & Emerging Drugs, European Regulatory Affairs, Clinical Research and Regulatory Affairs, Journal of Financial Regulation and Compliance, Brazilian Journal of Medical and Biological Research, European regulatory guidelines for biosimilars

Japan regulatory guidelines

The pharmaceutical regulatory authority of Japan is the Pharmaceutical and Food Safety Bureau (PFSB) of the MHLW. This is where the decision for application approval is formally made. Two other bodies deal with the pharmaceutical industry on a day-to-day basis. The Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), usually known as “The Center,” is the actual decisionmaker for approval of new drug applications (NDAs).

Related Journals of Japan regulatory guidelines

Journal of Pharmaceutical Sciences & Emerging Drugs, Journal of Pharmaceutical Care & Health Systems, Journal of Pharmaceutics & Drug Delivery Research, Journal of pharmacy and pharmaceutical sciences, Pharmaceutical Journals Online, European Industrial Pharmacy, Bioanalysis Journal

Regulatory compliance

Regulatory compliance is an organization's adherence to laws, regulations, guidelines and specifications relevant to its business. Violations of regulatory compliance regulations often result in legal punishment, including federal fines.

Related Journals of Regulatory compliance

Journal of Pharmaceutical Care & Health Systems, Journal of Molecular Pharmaceutics & Organic Process Research, Journal of Pharmaceutics & Drug Delivery Research, Journal of pharmacy and pharmaceutical sciences, World Journal of Pharmaceutical Research, Journal of Financial Regulation and Compliance, The National Law Journal, Journal of Financial Regulation and Compliance, Compliance and Regulatory Journal

Pharmaceutical companies and regulatory guidelines

The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals for use as medications. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. The guidelines developed by WHO are prepared through a vast global consultative process involving WHO Member States, national authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc. The draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards.

Related Journals of Pharmaceutical companies and regulatory guidelines

Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutics & Drug Delivery Research, Journal of Pharmaceutical Care & Health Systems, Journal of Molecular Pharmaceutics & Organic Process Research, Pharmaceutical Regulatory Affairs, Asian Journal of Pharmaceutical Technology and Innovation, Internationsl Journal of Drug Regulatory Affairs

Europian regulatory guidelines

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing-authorisation applications for human medicines. Guidelines provide a basis for practical harmonisation of how the EU Member States and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy that are in the Community directives.

Related Journals of Europian regulatory guidelines

Journal of Pharmaceutics & Drug Delivery Research, Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutical Care & Health Systems, Journal of Molecular Pharmaceutics & Organic Process Research, Clinical Research and Regulatory Affairs, Generics and biosimilars initiative Journal

Regulatory services and market analysis

Pharmaceutical Regulatory Services is a provider of expert clinical and regulatory support of all phases of global drug development. We support clinical and regulatory activities in the USA, European Union, as well as the emerging markets of Asia Pacific, Latin America, and Central and Eastern Europe. A market analysis studies the attractiveness and the dynamics of a special market within a special industry. It is part of the industry analysis and thus in turn of the global environmental analysis. Through all of these analyses the strengths, weaknesses, opportunities and threats (SWOT) of a company can be identified.

Related Journals of Regulatory services and market analysis

Journal of Diagnostic Techniques and Biomedical Analysis, Journal of Pharmaceutical Analysis, Journal of Pharmaceutical Care & Health Systems, Journal of Pharmaceutics & Drug Delivery Research, International Journal of Drug Regulatory Affairs, Clinical Research and Regulatory Affairs, International Journal of Drug Regulatory Affairs, International Journal of Pharma Research & Review (IJPRR)

Medical devices regulations

The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. For example, legal terms and their meanings are sometimes non-uniform even within one regulatory system. In an attempt to make this complex subject easier to grasp, this Guide presents a common framework that integrates the regulatory systems of the five countries or regions with the most advanced medical device regulations.

Related Journals of Medical devices regulations

Journal of Biomedical Engineering and Medical Devices, Advances in Weight Loss Management & Medical Devices, Journal of Diagnostic Techniques and Biomedical Analysis, Journal of pharmacy and pharmaceutical sciences, Advances in Weight Loss Management & Medical Devices, Journal of Medical device Regulation, Journal of Medical Devices

US FDA guidelines

United State Food and Drug Administration (USFDA) provides the sterile and non-sterile pharmceutical guidelines for industries. USFDA UPDATES THESE GUIDELINES time to time the provides to their users. All the USFDA approves plants have to follow these guidelines throughout the world.USFDA provides the pharmaceutical guidelines for all the stages from raw material to finished pharmaceutical products.

Related Journals of US FDA guidelines

Intellectual Property Rights: Open Access, Journal of Pharmaceutics & Drug Delivery Research, Journal of Pharmaceutical Care & Health Systems, Journal of Applied Pharmacy, International Journal of Drug Regulatory Affairs, Clinical Research and Regulatory Affairs, International Journal of Pharma Research & Review (IJPRR)

Regulatory consulting and market analysis

Financial and capital markets are transforming to adapt to new regulations and compliance requirements. Data-heavy organizations need to respond with minimum disruption.The market analysis is one of the most important parts of any startup strategy. Do it right, and you will have a clear idea of the path down which you are headed. A good market analysis will enable you to lure investors, sidestep pitfalls, and most importantly, attract customers.

Related Journals of Regulatory consulting and market analysis

Journal of Diagnostic Techniques and Biomedical Analysis, Journal of Pharmaceutical Analysis, Journal of Pharmaceutical Care & Health Systems, Journal of Pharmaceutics & Drug Delivery Research, The Journal of Direct, Data and Digital Marketing Practice, International Journal of Regulation and Governance, Energy Economics

Biopharmaceutics

Biopharmaceutics also known as a biologic medical product or biologic is any medicinal product manufactured in extracted from or semisynthesized from biological sources.

Related Journals of Biopharmaceutics

Clinical Pharmacology & Biopharmaceutics, Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutics & Drug Delivery Research, Journal of Molecular Pharmaceutics & Organic Process Research, European Journal of Pharmaceutics and Biopharmaceutics, Journal of Applied Biopharmaceutics and Pharmacokinetics, Journal of Biopharmaceutics and Biotechnology, Biopharmaceutics & Drug Disposition, International Journal of Biopharmaceutics.

Pharmaceutical care

Pharmaceutical care is the direct or indirect responsible provision of drug therapy for the purpose of achieving the elimination or reduction of a patient's symptomatology; arresting or slowing of a disease process; or preventing a disease or symptomatology.

Related Journals of Pharmaceutical care

Journal of Pharmaceutical Care & Health Systems, Journal of pharmacy and pharmaceutical sciences, Journal of Pharmaceutics & Drug Delivery Research, Journal of Molecular Pharmaceutics & Organic Process Research, Journal of Pharmaceutical Care, Pharmaceutical Care and Research, Journal of Pharmaceutical Health Care and Sciences (JPHCS), Indian Journal of Pharmacy Practice (IJOPP), Journal of Managed Pharmaceutical Care Impact Factor & Information

Drug devices

Drug delivery devices are specialized tools for the delivery of a drug or therapeutic agent via a specific route of administration. Such devices are used as part of one or more medical treatments.

Related Journals of Drug devices

Journal of Biomedical Engineering and Medical Devices, Advances in Weight Loss Management & Medical Devices, Journal of Diagnostic Techniques and Biomedical Analysis, Journal of pharmacy and pharmaceutical sciences, Drug Delivery and Translational Research, Journal of Food and Drug Analysis, Drugs and Devices, The England Journal of Medicine
 

* 2015 Journal Impact Factor was established by dividing the number of articles published in 2013 and 2014 with the number of times they are cited in 2015 based on Google search and the Scholar Citation Index database. If 'X' is the total number of articles published in 2013 and 2014, and 'Y' is the number of times these articles were cited in indexed journals during 2015 then, impact factor = Y/X

Recently Published Articles

 
 
 
 
 
 
 
 
OMICS International Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
 
 
OMICS International Conferences 2016-17
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings
 
 

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

agrifoodaquavet@omicsonline.com

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

clinical_biochem@omicsonline.com

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

business@omicsonline.com

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

chemicaleng_chemistry@omicsonline.com

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

environmentalsci@omicsonline.com

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

engineering@omicsonline.com

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

generalsci_healthcare@omicsonline.com

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

genetics_molbio@omicsonline.com

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

immuno_microbio@omicsonline.com

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

omics@omicsonline.com

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

materialsci@omicsonline.com

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

mathematics_physics@omicsonline.com

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

medical@omicsonline.com

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

neuro_psychology@omicsonline.com

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

pharma@omicsonline.com

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

social_politicalsci@omicsonline.com

1-702-714-7001 Extn: 9042

 
© 2008-2016 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version