Relevant bibliographies by topics / Dossier Registration

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Reports

Academic literature on the topic 'Dossier Registration'

Author: Grafiati
Published: 5 June 2025
Last updated: 1 August 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'Dossier Registration.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "Dossier Registration"

1

Mallol, J. "Registration dossier for radiopharmaceutical products." Pharmaceuticals, Policy and Law 17, no. 1,2 (2015): 213–20. http://dx.doi.org/10.3233/ppl-140408.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Lobovikova, O. A., I. V. Shul'gina, E. G. Abramova, et al. "REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW)." Drug development & registration 8, no. 1 (2019): 92–96. http://dx.doi.org/10.33380/2305-2066-2019-8-1-92-96.

Full text
Abstract:
Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out in the documents of the registration dossier for the drug. During the life cycle of a drug, post-registration changes in the dossier may be required. Text. This work is an analytical review of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blo
APA, Harvard, Vancouver, ISO, and other styles
3

Keloth Mounika, Y. Sirisha, and K. Nagasree. "Planning and execution of dossier compilation of countries Germany, Canada and Australia." International Journal of Allied Medical Sciences and Clinical Research 11, no. 4 (2023): 405–12. http://dx.doi.org/10.61096/ijamscr.v11.iss4.2023.405-412.

Full text
Abstract:
To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. When submitting your drug benefit assessments to the German Authority or other (foreign) regula
APA, Harvard, Vancouver, ISO, and other styles
4

Godiyal, Shrikant. "Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format." International Journal of Drug Regulatory Affairs 7, no. 2 (2019): 51–61. http://dx.doi.org/10.22270/ijdra.v7i2.318.

Full text
Abstract:
To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical docu
APA, Harvard, Vancouver, ISO, and other styles
5

Snegireva, I. I., E. O. Zhuravleva, and N. Yu Velts. "Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier." Safety and Risk of Pharmacotherapy 8, no. 4 (2020): 191–97. http://dx.doi.org/10.30895/2312-7821-2020-8-4-191-197.

Full text
Abstract:
The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registratio
APA, Harvard, Vancouver, ISO, and other styles
6

Margerison, Richard. "Recommendations for a Truly International Registration Dossier." Drug Information Journal 23, no. 3 (1989): 417–20. http://dx.doi.org/10.1177/009286158902300314.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Pihwal, Kapil, Neelam Pawar, Sheikh Aamir, Mohammad Shahbaz Alam, and Vikas Rathee. "A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries." Applied Clinical Research, Clinical Trials and Regulatory Affairs 7, no. 3 (2020): 162–76. http://dx.doi.org/10.2174/2213476x07666200708105237.

Full text
Abstract:
Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The r
APA, Harvard, Vancouver, ISO, and other styles
8

Shulgina, I. V., O. A. Lobovikova, O. A. Voloh та ін. "Review of Post-registration Changes in the Life Cycle of Сholera Bivalent Chemical Vaccine (Review)". Drug development & registration 9, № 1 (2020): 109–14. http://dx.doi.org/10.33380/2305-2066-2020-9-1-109-114.

Full text
Abstract:
Introduction. The inevitable of post-registration variations due to the improvement of production processes and quality control related to the integration of the modern technological solutions, replacement of equipment, suppliers of raw, consumables and packaging materials, improvement of form release or composition, administrative changes, as well as obtaining new data on clinical efficacy and safety of immunobiological medicinal products (IMP) during post-marketing studies.Text. The purpose of this work is to analyze the post-registration changes in the life cycle of IMP «Сholera bivalent ch
APA, Harvard, Vancouver, ISO, and other styles
9

Singam, Sri Lakshmi Sowjanya Reddy, Koushik Yetukuri, and Rama Rao Nadendla. "Drug Registration requirements for Pharmaceuticals in Emerging markets." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 73–82. http://dx.doi.org/10.22270/ijdra.v8i4.442.

Full text
Abstract:
Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising ma
APA, Harvard, Vancouver, ISO, and other styles
10

Foteeva, A. V., O. S. Barshadskaya, and N. B. Rostova. "Description of the System of State Registration of Medicines in the Republic of Georgia as a Development Potential of Domestic Manufacturers." Drug development & registration 10, no. 2 (2021): 155–61. http://dx.doi.org/10.33380/2305-2066-2021-10-2-155-161.

Full text
Abstract:
Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs registration procedure.Aim. The purpose of this study is to overview general aspects of registration procedure for generic drugs in Georgia for potential launching on pharmaceutical market.Materials and methods. For research purposes we have utilized data obtained from research articles, official websites, regulatory documents for drug registration proce
APA, Harvard, Vancouver, ISO, and other styles
More sources

Dissertations / Theses on the topic "Dossier Registration"

1

Molokwane, Mmamaswa Flucia. "The effect of dossier farming on medicine registration in South Africa." University of the Western Cape, 2020. http://hdl.handle.net/11394/7872.

Full text
Abstract:
Magister Pharmaceuticae - MPharm<br>In this study, the researcher wanted to determine the effect of dossier farming in medicine registration in South Africa by comparing the number of generic registrations of products tendered for the government for the molecules enalapril, amlodipine and losartan, before and after innovator patent expiration and quantified the extent it is practiced and how it affected medicine registration backlog.
APA, Harvard, Vancouver, ISO, and other styles
2

Sekhonyana-Khetsekile, Mabolaeng. "The development and preparation of a quality control dossier for registration of Artemisia Afra capsules for the treatment of chronic Asthma by the South African health products regulatory authority." University of the Western Cape, 2018. http://hdl.handle.net/11394/6432.

Full text
Abstract:
Magister Pharmaceuticae - Mpharm<br>The aim of this study was to determine quality control specifications needed for a dossier and an investigator's brochure of A. afra capsules, which can be used to motivate the registration and clinical testing of A. afra capsules in chronic asthma. The specific objectives were: (1) to establish the minimum product quality requirements for registration of A. afra capsules, (2) to prepare and pharmaceutically characterize a capsule product of A. afra freeze dried aqueous extract (FDAE) suitable for registration, and (3) to identify pharmaceutical product qual
APA, Harvard, Vancouver, ISO, and other styles

Books on the topic "Dossier Registration"

1

France. Ambassade (Madagascar). Service de coopération et d'action culturelle. and Projet d'appui à la réhabilitation de l'état civil (Madagascar), eds. Dossier d'archivage pour l'état civil malgache à l'attention des mairies et des tribunaux de prèmieres instances. Projet d'appui à la réhabilitation de l'état civil, 2003.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
2

(Editor), Richard S. Dick, Elaine B. Steen (Editor), and Don E. Detmer (Editor), eds. The Computer-Based Patient Record: An Essential Technology for Health Care, Revised Edition. 2nd ed. National Academies Press, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
3

Computer-Based Patient Record: An Essential Technology for Health Care, Revised Edition. National Academies Press, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
4

Computer-Based Patient Record: An Essential Technology for Health Care, Revised Edition. National Academies Press, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
5

Abbey, L. M., K. A. Bartholomew, C. S. Burger, H. D. Cross, and Lawrence L. Weed. Knowledge Coupling: New Premises and New Tools for Medical Care and Education. Springer, 2012.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
6

Abbey, L. M., K. A. Bartholomew, C. S. Burger, H. D. Cross, and Lawrence L. Weed. Knowledge Coupling: New Premises and New Tools for Medical Care and Education. Springer, 2011.

Find full text
APA, Harvard, Vancouver, ISO, and other styles

Book chapters on the topic "Dossier Registration"

1

"Update of the Registration Dossier." In REACH Compliance - The Great Challenge for Globally Acting Enterprises. Wiley-VCH Verlag GmbH & Co. KGaA, 2013. http://dx.doi.org/10.1002/9783527664290.ch11.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

"Obligation to Submit a Registration Dossier." In REACH Compliance - The Great Challenge for Globally Acting Enterprises. Wiley-VCH Verlag GmbH & Co. KGaA, 2013. http://dx.doi.org/10.1002/9783527664290.ch4.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

"What Happens after Submission of Your Registration Dossier to ECHA?" In REACH Compliance - The Great Challenge for Globally Acting Enterprises. Wiley-VCH Verlag GmbH & Co. KGaA, 2013. http://dx.doi.org/10.1002/9783527664290.ch10.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

K. Al-Essa, Reem, and Donia A. Al-Bastaki. "Building Quality into the Regulatory Review Practice for Competent Authorities." In Drug Development and Safety [Working Title]. IntechOpen, 2024. http://dx.doi.org/10.5772/intechopen.114314.

Full text
Abstract:
The aim of this chapter is to discuss how competent authorities build quality into their assessment and registration process of medicines and to address possible challenges and opportunities for timely access to safe, effective, and high-quality medicines. Details of quality attributes which characterize the extent of scientific assessments will be the main focus. Such attributes will require solid quality management tools in place the for establishing and maintaining a proper regulatory system. Global harmonization of the regulatory review processes was achieved by the introduction of the Com
APA, Harvard, Vancouver, ISO, and other styles

Reports on the topic "Dossier Registration"

1

ter Horst, Mechteld, June Akinyi Aluoch, Maurice Wanyonyi Barasa, et al. Guidance on dossier evaluation for the registration of pest control products in Kenya. Wageningen Environmental Research, 2019. http://dx.doi.org/10.18174/510074.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Mashingia, Jane, S. Maboko, P. I. Mbwiri, et al. Joint Medicines Regulatory Procedure in the East African Community: Registration Timelines and Way Forward. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317429.

Full text
Abstract:
A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review
APA, Harvard, Vancouver, ISO, and other styles
3

ter Horst, Mechteld, June Akinyi Aluoch, Maurice Wanyonyi Barasa, et al. Implementation of guidance on dossier evaluation for the registration of pest control products in Kenya. Wageningen Environmental Research, 2019. http://dx.doi.org/10.18174/510075.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Usai, Jannet, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Herbal Medicines Registration Process for Zimbabwe Overview of the Process. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317434.

Full text
Abstract:
Unregistered traditional medicines pose a huge public health threat as the safety and efficacy of these products is unknown. The issue this study addresses is the inadequate regulatory measures for herbal medicines in Zimbabwe. This project was done to describe the current registration process of traditional medicines in Zimbabwe, and to identify the gaps and opportunities they present to improve the regulatory landscape. Regulations and laws governing the registration of herbal medicines in the country and published research on legislation of herbal medicines were reviewed. Two parallel regul
APA, Harvard, Vancouver, ISO, and other styles
You might also be interested in the extended bibliographies on the topic 'Dossier Registration' for particular source types:
Journal articles
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography