Pharmaceutical Industry Departments and its roles and responsibilities were discussed. Product selection, Development, Manufacturing, Product approval, Marketing
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...balakrishna t
tQmlab® is the premier management system for GxP operations and for supporting regulatory submissions. It delivers transformational productivity for QA/QC labs supporting customised workflows for quality control of drugs, stability testing, product release testing and post-release quality testing.
Artixio MedTech Training Brochure 2023.pdfY. Yogi Raj
Product Technical Documents for Regulatory Submissions
Regulatory Submissions - US FDA
Regulatory Submissions - EU
The Medical Device Regulation (MDR)
The In Vitro Diagnostic Medical Device Regulation (IVDR)
ISO 13485:2016 - General Overview and Training
Risk management ISO 14971
Regulatory Submissions - APAC
Regulatory Submissions - LATAM
Regulatory Submissions - ANZ
Quality Management System - Development
Quality Management System - Implementation
Labelling for Global Regulatory Submissions
UDI - EUDAMED Requirements
Medical Writing for Regulatory Submissions
Clinical Evaluation - Plan and Report
Performance Evaluation - Plan and Report
Post Marketing Surveillance Requirements
Medical Device Standards Training
Notified Bodies Experience
FAMI-QS Certification What You Need to Know.pdfOFFICE
FAMI-QS is a preeminent global Quality and Feed Safety Management System for the sector of Specialty Feed Ingredients. A Specialty Feed Ingredient is defined as any intentionally added ingredient, not normally consumed as feed by itself, whether or not it has nutritional value, which affects the characteristics of feed or animals/ animal products and animal performance.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Commrcialization is the process of bringing new product to services to market . The broader act of commercializ
Commercialization is the process of bringing new product to services to market. The broader act of commercialization entails production, distribution, marketing, sales, customer support, and other key function critical to achieving the commercial success of the new product or service.
Collapsing Narratives: Exploring Non-Linearity • a micro report by Rosie WellsRosie Wells
Insight: In a landscape where traditional narrative structures are giving way to fragmented and non-linear forms of storytelling, there lies immense potential for creativity and exploration.
'Collapsing Narratives: Exploring Non-Linearity' is a micro report from Rosie Wells.
Rosie Wells is an Arts & Cultural Strategist uniquely positioned at the intersection of grassroots and mainstream storytelling.
Their work is focused on developing meaningful and lasting connections that can drive social change.
Please download this presentation to enjoy the hyperlinks!
This presentation, created by Syed Faiz ul Hassan, explores the profound influence of media on public perception and behavior. It delves into the evolution of media from oral traditions to modern digital and social media platforms. Key topics include the role of media in information propagation, socialization, crisis awareness, globalization, and education. The presentation also examines media influence through agenda setting, propaganda, and manipulative techniques used by advertisers and marketers. Furthermore, it highlights the impact of surveillance enabled by media technologies on personal behavior and preferences. Through this comprehensive overview, the presentation aims to shed light on how media shapes collective consciousness and public opinion.
Obesity causes and management and associated medical conditions
Pharmaceutical Industry Departments roles and responsibilities manasa life sciences
1. Pharmaceutical Industry
Departments Roles and
Responsibilities
Dr. Useni Reddy Mallu
Mobile: 7901020060
E-mail: info@manasalifesciences.com
Website: www.manasalifesciences.com
2. R&D AR&D DQA
SCM
Purchase Operations
Production
QA QC
Patents
Product Portfolio Marketing Logistics
Regulatory Affairs
Engineering Product Planning
Finance
Safety
Pharmacovigilance
Bio-Equivalence
Technology Transfer
Inspection team
Business development
Training Team
Licence team
Project Management
Selection Development Manufacturing MarketingApproval
Multi Functional Departments
26 Departments
8. Departments R & R
S.No. Departments R & R
1 Product Portfolio Drug profile, product biz volume, global requirement, drug
nature, investment value, product time lines
2 Business development Product competitors, biz volume, target countries,
development time lines, material cost
3 Project management Product time lines, development and stability time lines,
innovator samples, logistics time lines
4 Finance Investment value, product life time, approval time,
expenditure
5 R&D Product development, quality material sourcing, quality
evaluation, lab scale stability, BABE studies, product
technology transfer
6 AR&D Method development, validation, specifications, stability
studies, vendor qualification, impurity profile
7 DQA Documentation practice, technology transfer, vendor
qualification, training program
8 Technology transfer Product transfer, suitability of equipment, documentation
practice, auditable document
9 SCM Material sourcing, vendor qualification, alternate vendor,
material costing
9. Departments R & R
S.No. Departments R & R
10 Bioequivalence BABE studies, bio results, number of subjects
11 Quality assurance Documentation practice, vendor qualification, facility audit,
inspections, employee training, safety, material entry and exit
12 Quality control Product analysis, method verification, method validation,
instruments qualification, vendor qualification, analyst training
13 Purchase Vendor selection, vendor evaluation, material inventory, material
sourcing
14 Production Product manufacturing, documentation practice, product
planning, employee training, material entry to exit
15 Regulatory affairs Product submission, regulatory guidance implementation,
product approval, deficiencies, product life cycle, CTD
submission
16 Inspection team Inspection leading, customer and agency audits, warning letters,
inspection requirements
17 Pharmacovigilance Approved product life cycles, market complaints, product quality,
patient complaints
10. Departments R & R
S.No. Departments R & R
18 Marketing Product marketing, marketing companies support, logistics,
finished product inventory, product sales
19 Logistics Product transport, custom clearance, material safety,
20 Training team Employee training, product training, equipment training
21 Safety Safety requirements, safety organogram, safety
measurements, safety training
22 Licence team Product submission, product licence, market complaints
23 Product planning Product time lines, product manufacturing, pipe line
production schedule
24 Operations Production monitoring, plant activities, public complaints,
product planning, material inventory, casual employee
management
25 Patents Innovator patents, patent claims, patent expiry, patent
challenge, product requirements
26 Engineering Equipment qualification, new equipment installation,
training, equipment service, breakdown monitoring