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GLP certification in Malaysia
 Introduction
For laboratories conducting research, testing, and analysis, Good Laboratory Practise (GLP) certification is an essential quality assurance requirement in Malaysia. In their scientific endeavors, laboratories must uphold high data integrity, precision, and dependability requirements. The Malaysian government and other pertinent organizations have severe rules and regulations that laboratories must follow in order to receive GLP certification there. These rules include a wide range of topics, such as documentation, calibration of the equipment, training for employees, and quality control procedures. Acquiring GLP accreditation displays a dedication to delivering reliable and consistent results, enhancing the validity of the laboratory's operations, and promoting cross-border cooperation in R&D initiatives.
What are the benefits of GLP certification in Malaysia?
Quality Control: GLP certification assures that laboratories uphold strict criteria for accuracy, data integrity, and quality in all of their operations. This improves the accuracy of the findings and aids in avoiding mistakes or discrepancies.
Credibility: The GLP accreditation raises the work of the laboratory's credibility. It shows a dedication to delivering consistent and trustworthy results, which is essential for winning the confidence of customers, collaborators, and regulatory agencies.
Compliance: For several kinds of research and testing, regulatory compliance with GLP criteria is frequently necessary. A laboratory can be particular in that it is by both Malaysian laws and global standards by obtaining GLP accreditation.
International Collaboration: Because GLP certification attests to adherence to internationally acknowledged quality standards, it is simpler for Malaysian laboratories to work with foreign partners.
Risk reduction: By adhering to GLP standards, labs can lower their risk of expensive mistakes, losing information, and governmental non-compliance, which could result in fines or reputational harm.
Efficiency: GLP practices, such as correct documentation, equipment upkeep, and staff training, support efficient laboratory operations. Cost reductions and increased productivity may result from this.
What is the procedure for GLP Certification in Malaysia?
Understanding GLP Requirements: To start, become familiar with those GLP requirements and recommendations that are relevant to your particular testing or research field. Data integrity, dependability, and quality control are the main tenets of GLP.
Laboratory Setup: Assure that your facilities, equipment, and infrastructure all adhere to GLP standards. This covers safe practices, proper equipment calibration and maintenance, and laboratory design.
Make sure that laboratory staff members are adequately trained and educated in GLP theories and practices. Records, apparatus verification, assurance of quality, and standard procedures for operation (SOPs) should all be covered in training.
Developing a strong quality management system (QMS) that includes SOPs for all laboratory activities is essential. Procedures for handling samples, capturing data, and reporting should be documented.
Develop secure data management procedures to preserve the accuracy and traceability of your data. Data restoration, data retention guidelines, and computer record-keeping systems are all included in this.
Implement quality control procedures to monitor and confirm the accuracy and dependability of test results. Implement independent audits and reviews frequently to ensure compliance.
Conclusion about how to get  GLP certification for Malaysia?
GLP (Good Laboratory Practise) certification requires a stringent commitment to quality standards in Malaysia. Learn about GLP requirements first, and then teach lab staff. Ascertain that the infrastructure, tools, and data management procedures satisfy the requirements. Create a thorough quality assurance system (QMS) with detailed procedures, placing a focus on data integrity and precise record-keeping. Implement stringent quality assurance procedures, and keep detailed records of all laboratory activities.
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Benefits of GLP Certification in Malaysia
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/ Uncategorized / By Mysore intr
What is GLP Certification in Malaysia?
GLP Certification in Malaysia, Good Laboratory Practice (GLP) certification in Malaysia is a globally identified quality gadget ensuring the integrity and reliability of non-medical laboratory studies. It sets stringent requirements for the behavior, tracking, and documentation of non-scientific studies, ultimately guaranteeing the pleasantness and protection of drugs, chemical substances, and products developed primarily based on such facts.
Advantages of GLP Certification in Malaysia:
Obtaining GLP certification in Malaysia offers numerous blessings for numerous stakeholders:
1. Enhanced Research Quality and Reliability: GLP practices limit mistakes, biases, and contamination, main to more robust and dependable studies facts, facilitating knowledgeable choice-making in drug improvement and regulatory processes.
2. Streamlined Regulatory Approval: GLP certification in Malaysia demonstrates compliance with national and global rules, leading to quicker product approvals and decreased regulatory hurdles.
3. Global Recognition and Acceptance: As a globally identified general, GLP certification in Malaysia opens doors for Malaysian laboratories and groups to collaborate with international companions and get entry to worldwide markets.
4. Increased Investor Confidence: Investors understand GLP certification in Malaysia as a mark of fine and commitment to scientific rigor, attracting capacity investment and boosting investor confidence.
5. Improved Operational Efficiency: Implementing GLP practices streamlines tactics, reduces errors, and ultimately increases operational performance and fee savings.
GLP Auditors in Malaysia:
The Good Laboratory Practice Compliance Monitoring Committee (GLPCMC), operating underneath the National Pharmaceutical Regulatory Agency (NPRA), appoints GLP auditors liable for inspections and assessing laboratories’ compliance with GLP requirements. These auditors understand various clinical disciplines and undergo rigorous education to ensure they continuously apply GLP ideas and conditions at some point of inspection.
Requirements for GLP Certification in Malaysia:
To obtain GLP certification in Malaysia, laboratories have to follow the following key requirements:
1. Personnel: Employ certified and skilled personnel with the necessary expertise and competencies to conduct non-scientific studies adhering to GLP ideas.
2. Facilities and Equipment: Maintain suitable and properly maintained facilities and calibrated systems to ensure the proper behavior of non-clinical research and facts integrity.
3. Quality Management System: Implement a strong and comprehensive control machine that encompasses all factors of GLP compliance.
4. Standard Operating Procedures (SOPs): Establish and adhere to documented SOPs for all tactics, processes, and sports concerned in non-clinical research.
5. Documentation and Records: Maintain certain and correct records of all. Take a look at tactics, facts, and findings.
6. Archiving and Retention: Implement a machine for archiving and securely keeping observed records for a detailed period, as mandated with the aid of rules.
7. Quality Assurance and Audits: Conduct ordinary inner audits and participate in external inspections using the GLPCMC to evaluate and improve GLP compliance.
GLP Costs in Malaysia:
The expenses related to GLP certification in Malaysia can vary depending on numerous factors, including the laboratory’s scale and complexity, the scope of non-scientific studies, and the chosen certification frame. Generally, expenses involve:
Application costs: Payable to the GLPCMC for processing the application.
Pre-assessment costs: Paid to chosen pre-assessment carrier vendors.
Audit prices: Paid to the GLPCMC or authorized audit our bodies accomplishing the certification inspection.
Implementation prices: Include prices related to personnel education, facility enhancements, system calibration, and excellent management gadget development.
Maintenance prices: Ongoing charges for preserving GLP compliance, inclusive of inner audits, workforce training, and system updates.
Conclusion:
While the preliminary funding in GLP certification in Malaysia may additionally appear large, the lengthy-term advantages for stakeholders outweigh the expenses. Enhanced research, faster regulatory approvals, admission to international markets, and accelerated investor confidence ultimately contributed to the boom and success of the Malaysian pharmaceutical and life sciences industry.
Why Factocert for GLP Certification in Malaysia
We provide the best GLP Certification in Malaysia, Who are very knowledgeable and provide the best solution. And to know how to get GLP Certification in Malaysia. GLP Certification Consultants work according to GLP standards and help organizations [email protected].  implement GLP certification in with proper documentation.
For more information visit: GLP Certification in Malaysia
Related Links:
GMP Certification in Malaysia
GDP Certification in Malaysia
GLP Certification in Malaysia
RoHS Certification in Malaysia
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decisionforsight · 3 years
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Global Digital Pathology Market
Global Digital Pathology Market Size, Share, Growth, Industry Trends and Forecast 2020-2030
Global Digital Pathology Market accounted USD 721.7 million in 2020 and is anticipated to reach USD 2281.7469 million by 2030, at a CAGR of 12.2% during the forecast period. It is an innovation predominantly committed to minimize laboratory expenses, increase operational efficiency, improving treatment decisions and patient care, and improved overall productivity. This technique incorporates the management, acquisition, sharing and interpretation of pathology information — which include slides and data — in a digital environment. Digital slides are produced when glass slides are apprehended with a scanning device, to deliver a high-resolution digital image that can be observed on a computer screen or mobile device. Virtual microscopy is a part of the market which enables to practice converting glass slides into digital slides that can be viewed, managed, shared and analyzed on a computer monitor. Among other applications of the market, digitalization of pathology has led to the mechanization of tests during disease diagnosis. The market proposes analysis & interpretation of images on a computer, high-resolution sample scanning, and online storage of digital slides, which enable pathologists to cross-examine slides without physical evidences. These digitized slides are presently considered as one of the most promising areas of diagnostic medicine in order to achieve accurate, feasible and faster diagnosis, prognosis and prediction of cancer and other important diseases. It is progressively used by large biopharmaceuticals and top clinical research organizations (CROs) to rationalize drug progress methods in discovery, pre-clinical and clinical trials.
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Market Dynamics and Factors:
According to WHO cancer facts and figures, in 2018, approximately 1,735,350 new cases of cancer were diagnosed in the United States and it is anticipated that approximately 609,640 people will die from the disease. Rising severity of cancer is projected to create a high demand for the market. Biotech and pharma companies are predicted to show a stable growth during the forecast period. The growth is credited to enlarged use digitized slides in drug development, oncology clinical trials, and preclinical GLP pathology. The increasing application in drug discovery, increasing number of tele-consultations, rising adoption of technology to improve lab efficiency, and companion diagnostics are driving the market globally. However, unclear reimbursement policies, dearth of skilled personnel, and unwillingness of older pathologists to adopt new technology hamper the digital pathology market growth. Moreover, large hospitals with significant capital budgets can afford these systems, pathologists and academic institutes with limited budgets or IT support often cannot afford them. This limits the uptake of these systems. On the other hand, rise in initiatives toward commercialization of cost-efficient systems and increasing R&D is anticipated to offer profitable growth opportunities the market and its service providers in the future.
Market Segmentation:
Global Digital Pathology Market – By Product
Scanners
Software
Storage & Communication Systems  
Global Digital Pathology Market – By Application
Tele-Consultation
Disease Diagnosis
Drug Discovery
Academic Research
Diagnosis
Global Digital Pathology Market – By End-User
Educational
Clinical
Pharmaceutical Industries & Biotech Companies
Global Digital Pathology Market – By Geography
North America
U.S.
Canada
Mexico
Europe
U.K.
France
Germany
Italy
Rest of Europe
Asia-Pacific
Japan
China
India
Australia
Rest of Asia Pacific
ROW
Latin America
Middle East
Africa
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Geographic Analysis:
In 2018, North America held the largest market share in terms of revenue and it is expected to dominate the overall market throughout the forecast period. The presence of high per capita healthcare expenditure,  Continual deployment of R&D investments, and the well-established IT and healthcare infrastructure and the presence of major players are the key contributing factors contributing to the growth of the market in the region. Furthermore, clinical segment will show fastest market growth due to rise in number of clinics incorporating digital pathology over traditional pathology, which is expected to augment the market growth. Moreover the surge in adoption of modern technology over the traditional methods boost the growth of the market in North America. However, Asia-Pacific is expected to record itself as highest growing segment during the forecasted period, at a CAGR of 13.4%; in the near future, owing to emergence in awareness related to the market. The other factors that propel the growth of the market comprise the existence of huge patient’s base suffering from chronic & infectious diseases and rise in healthcare expenditure in the region. Furthermore, the constantly evolving life science industry is anticipated to offer lucrative opportunities for the market expansion in the developing economies such as India, China, and Malaysia.  Asia Pacific is expected to register the fastest CAGR of over 12% during the forecast period due to the rising penetration of digital imaging in emerging economies, investments in the medical field, and the presence of available opportunities like increased RnD activities and various government initiatives towards healthcare. The healthcare industry in this region has highly influenced the market due to increased incidence of cancer, which affects a large population. Similarly, increasing demand for novel treatment options, reduction in laboratory expenses, and better patient care facilities are expected to further drive the demand.
Competitive Scenario:
The major players operating in the market include Leica Biosystems, Ventana Medical Systems, Hamamatsu Photonics, 3DHISTECH, Philips, Apollo Enterprise Imaging, XIFIN, Visiopharm, Corista, Huron Digital Pathology, Objective Pathology Services, and Indica Labs.
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The report offers statistical data in terms of value (US$) as well as Volume (units) till 2030.
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The report tracks the leading market players that will shape and impact the Global Digital Pathology Market most.
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Global Sarcopenia Treatment Market Forecast Report by Data Bridge Market Research Offers Key Insights
Thorough and transparent research studies conducted by a team work of experts in their own domain accomplish this global Sarcopenia Treatment Market research report. The report is valuable for both customary and emerging market players in the industry and provides in-depth market insights. This report is a great example of such wide-ranging market information which explores practical growth strategies and recommendations related to Pharmaceutical industry. This Sarcopenia Treatment Market research report serves the businesses with making enhanced decisions, deal with marketing of goods or services, and accomplish better profitability by prioritizing market goals.
Sarcopenia is a progressive skeletal muscle disorder. It involves the loss of muscle mass and strength due to natural aging process. This condition affects the gait and overall ability of body to perform normal tasks. According to International Osteoporosis Foundation (IOF), the muscle loss starts from the age of 40. The major causes of sarcopenia could be sedentary lifestyle, malnutrition and unhealthy food intake. The increasing population of people aged more than 60 and the increasing cases of malnutrition worldwide are the major factors augmenting the market growth.
Global Sarcopenia treatment market is rising gradually with a steady CAGR in the forecast period of 2019-2026. The growing prevalence of sarcopenia by increasing old age population and adoption of sedentary and unhealthy lifestyle is the major factor that contributes in the growth of global sarcopenia treatment market.
Get Sample Analysis of Global Market Information: https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-sarcopenia-treatment-market
Key Market Players:
Few of the major competitors currently working in the global sarcopenia treatment market are Novartis AG, AstaReal AB, Regeneron Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Biophytis, Metabolic Technologies, Inc., AbbVie Inc., Danone, Pfizer Inc., Abbott, Biogen, GlaxoSmithKline plc., F. Hoffmann-La Roche Ltd, Nestlé, Mitacs, Sanofi, Bayer AG, Amway, Zydus Cadila, Eli Lilly and Company, Radius Health, Inc., MYSURABLE S.R.L., PhaseBio Pharmaceuticals, Inc among others.
Market Drivers
Prevelance of geriatric population is expected to boost the market growth
Increasing adoption of vitamins and dietary supplements among the ageing population for better treatment of this disorder also acts as a market driver The prevalence of sarcopenia is high among old age population drives the global sarcopenia treatment market
Surging research and development activities for the treatment of sarcopenia also acts as a driver for this market
Rising cases of malnutrition due to poor nutritional intake can also augment the growth of this market
Market Restraints
Lack of awareness among people regarding the muscle loss can act as a major restraint for this market
Lack of skilled medical profession for the diagnosis of this disorder is also less; this factor can also restrict the growth of this market
High cost of protein supplement and unavailability of sarcopenia treatment drugs can also impede the market growth
Segmentation: Global Sarcopenia Treatment Market
By Treatment
Medication
Vitamin/ Dietary Supplements
Others
By Route of Administration
Oral
Injectable
By End Users
Hospitals
Homecare
Specialty Clinics
Others
By Distribution Channels
Hospital Pharmacy
Online Pharmacy
Retail Pharmacy
Others
By Geography
North America
South America
Europe
Asia-Pacific
Middle East & Africa
U.S.
Canada
Mexico
Brazil
Rest of South America
Germany
France
United Kingdom
Italy
Spain
Russia
Turkey
Belgium
Netherlands
Switzerland
Rest of Europe
Japan
China
South Korea
India
Australia
Singapore
Thailand
Malaysia
Indonesia
Philippines
Rest of Asia Pacific
South Africa
Rest of Middle East & Africa
Get TOC of Full Report: https://www.databridgemarketresearch.com/toc/?dbmr=global-sarcopenia-treatment-market
Key Developments in the Market:
In April 2019. MYSURABLE S.R.L., has developed mioTest, a system based on effective and scientifically validated tools that identifies the risk of sarcopenia. The system can also assess muscle mass composition including functionality and level of hydration of muscles in a beneficial and non-invasive way
In April 2019, PhaseBio Pharmaceuticals, Inc. licensed ImmunoForge, Co. Ltd. the global rights for PB1023, a recombinant GLP-1 analogue used for the treatment of patients with sarcopenia. ImmunoForge, Co. Ltd. is working on a pipeline for development of novel therapies for sarcopenia related diseases. PhaseBio Pharmaceuticals, Inc. will receive development milestone payments and royalty payments on the sales of the product by this licensed agreement
Competitive Analysis:
Global sarcopenia treatment market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of sarcopenia treatment market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.
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Global Sarcopenia Treatment Market Likely to Emerge over a Period of 2026
Global Sarcopenia Treatment Market By Treatment Type (Medication, Vitamin/Dietary Supplements and Others), Route of Administration (Oral, Injectable and Others), End-Users (Hospitals, Homecare, Specialty Clinics, Others), Distribution Channel (Hospital Pharmacy, Online Pharmacy, Retail Pharmacy, Others), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) - Industry Trends and Forecast to 2026
Market Analysis: Global Sarcopenia Treatment Market
Global Sarcopenia treatment market is rising gradually with a steady CAGR in the forecast period of 2019-2026. The growing prevalence of sarcopenia by increasing old age population and adoption of sedentary and unhealthy lifestyle is the major factor that contributes in the growth of global sarcopenia treatment market.
Market Definition: Global Sarcopenia Treatment Market
Sarcopenia is a progressive skeletal muscle disorder. It involves the loss of muscle mass and strength due to natural aging process. This condition affects the gait and overall ability of body to perform normal tasks. According to International Osteoporosis Foundation (IOF), the muscle loss starts from the age of 40. The major causes of sarcopenia could be sedentary lifestyle, malnutrition and unhealthy food intake. The increasing population of people aged more than 60 and the increasing cases of malnutrition worldwide are the major factors augmenting the market growth.
Get Sample Analysis of Global Market Information: https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-sarcopenia-treatment-market
Market Drivers
Prevelance of geriatric population is expected to boost the market growth
Increasing adoption of vitamins and dietary supplements among the ageing population for better treatment of this disorder also acts as a market driver The prevalence of sarcopenia is high among old age population drives the global sarcopenia treatment market
Surging research and development activities for the treatment of sarcopenia also acts as a driver for this market
Rising cases of malnutrition due to poor nutritional intake can also augment the growth of this market
Market Restraints
Lack of awareness among people regarding the muscle loss can act as a major restraint for this market
Lack of skilled medical profession for the diagnosis of this disorder is also less; this factor can also restrict the growth of this market
High cost of protein supplement and unavailability of sarcopenia treatment drugs can also impede the market growth
Segmentation: Global Sarcopenia Treatment Market
By Treatment
Medication
Vitamin/ Dietary Supplements
Others
By Route of Administration
Oral
Injectable
By End Users
Hospitals
Homecare
Specialty Clinics
Others
By Distribution Channels
Hospital Pharmacy
Online Pharmacy
Retail Pharmacy
Others
By Geography
North America
South America
Europe
Asia-Pacific
Middle East & Africa
U.S.
Canada
Mexico
Brazil
Rest of South America
Germany
France
United Kingdom
Italy
Spain
Russia
Turkey
Belgium
Netherlands
Switzerland
Rest of Europe
Japan
China
South Korea
India
Australia
Singapore
Thailand
Malaysia
Indonesia
Philippines
Rest of Asia Pacific
South Africa
Rest of Middle East & Africa
Get TOC of Full Report: https://www.databridgemarketresearch.com/toc/?dbmr=global-sarcopenia-treatment-market
Key Developments in the Market:
In April 2019. MYSURABLE S.R.L., has developed mioTest, a system based on effective and scientifically validated tools that identifies the risk of sarcopenia. The system can also assess muscle mass composition including functionality and level of hydration of muscles in a beneficial and non-invasive way
In April 2019, PhaseBio Pharmaceuticals, Inc. licensed ImmunoForge, Co. Ltd. the global rights for PB1023, a recombinant GLP-1 analogue used for the treatment of patients with sarcopenia. ImmunoForge, Co. Ltd. is working on a pipeline for development of novel therapies for sarcopenia related diseases. PhaseBio Pharmaceuticals, Inc. will receive development milestone payments and royalty payments on the sales of the product by this licensed agreement
Competitive Analysis:
Global sarcopenia treatment market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of sarcopenia treatment market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.
Key Market Players:
Few of the major competitors currently working in the global sarcopenia treatment market are Novartis AG, AstaReal AB, Regeneron Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Biophytis, Metabolic Technologies, Inc., AbbVie Inc., Danone, Pfizer Inc., Abbott, Biogen, GlaxoSmithKline plc., F. Hoffmann-La Roche Ltd, Nestlé, Mitacs, Sanofi, Bayer AG, Amway, Zydus Cadila, Eli Lilly and Company, Radius Health, Inc., MYSURABLE S.R.L., PhaseBio Pharmaceuticals, Inc among others.
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