Verbatim Pharma’s Post

Focus on Total Quality Management in manufacturing is crucial as it ensures continuous improvement, compliance, and customer satisfaction, elevating industry standards. These aspects collectively drive a culture of quality and compliance within the industry, benefiting health manufacturing, public health, and safety. 1. Employee Involvement - Engaging employees at all levels fosters a culture of ownership and accountability, leading to better quality outcomes in pharmaceutical operations. 2. Process-Centered - Prioritizing well-defined processes ensures consistency and reliability in drug development, manufacturing, and distribution. 3. Fact-Based Decision Making - Utilizes data-driven insights enabling informed choices, impacting efficacy and safety of products. 4. Integrated Systems - reduction of errors and promotion of seamless collaboration among departments lead to higher quality standards. 5. Strategic and Systematic Approach - This involves applying a structured methodology that aligns the organizational goals with quality objectives, ensuring every action contributes to its overall excellence. 6. Continuous Improvement - Constantly refining processes and methodologies is crucial for maintaining the highest quality standards in the industry. 7. Communication - Open, transparent, and effective communication is vital for ensuring that quality standards are understood, embraced, and consistently met by all stakeholders. 8. Focus on Customer - Placing the end-user at the center ensures that products meet or exceed their needs and expectations. #TotalQualityManagement #PharmaceuticalIndustry #QualityExcellence 🌐💊📊 #QualityAssurance #Pharmacovigilance

Unveiling the Role of Regulatory Affairs in Pharma Product Development: A crucial nexus between R&D, Clinical, and Regulations, these experts shape the product journey. From moulding Target Product Profiles to ensuring lifecycle compliance, they're architects of success. Early engagement crafts strategy, mitigates risks and harmonises diverse inputs. Meticulous documentation bridges stakeholders and authorities while adapting to evolving norms. Beyond obtaining marketing authorisation, they ensure sustained adherence to standards. With multidisciplinary prowess, they unify Quality, Compliance, Clinical, and Manufacturing domains. Leveraging over 20 years of industry acumen, ProductLife Group is your regulatory ally from inception to post-market pursuits. 👉 Read more on https://lnkd.in/dfpPeFqg and connect at contact@productlife-group.com for tailored solutions.   #PharmaRegulation #ProductLifeCycle #RegulatoryAffairsProfessional #RAinProductDevelopment #regulatoryaffairs #lifesciences #consulting #outsourcing  

What clinical supply managers are doing? It is not the same as a typical supply chain manager. The clinical supply chain manager is responsible for a drug starting from its production until it is delivered to the patient. The clinical supply manager is looking at the whole life of the clinical trial. The whole spectrum of GxP. Not only GCP. GMP part - APIs manufacturing from drug substance to the drug product at CDMO. Do not forget about primary and secondary packaging. GDP part - planning global distribution and everything that it entails: - Clinical CMO for packaging activities (cold chain, frozen, etc.) - Depot networks - Solution providers - Forecasts and supply optimisation companies The main idea here is to create solutions and help dreams for a better drug come true. While working on problems Clinical Supply Manager must build strong relationships with internal and external stakeholders. This is the most important part - having good relationships with all parties. Many times people will not listen not because they are arrogant, but just because they are busy. So repeat it again and again. It’s not about you or your ego. It’s about helping people live better lives. #clinicalsupply

Do you need support during the holiday period? ✈️ Summer is fast approaching, and with it the holiday period for many of your employees. While your team is enjoying a well-deserved rest, we understand that your tasks can't stand still. We offer temporary support in various areas: 👉 Interim Management: Ensure your projects and operations continue smoothly with our experienced interim managers. 👉 Consultancy Services: Get expert advice and solutions tailored to your needs. 👉 Quality Assurance/Quality Management: We help you develop, implement, and audit robust quality management systems compliant with ISO standards for life sciences organizations. Our services include CAPA support, internal audits, supplier management, validation (CSV and Data Integrity), and quality strategy development. 👉 Regulatory Affairs: Customized regulatory strategies for pharmaceutical, biotech, and medical device companies. We handle global regulatory submissions, gap assessments, regulatory training, and ongoing compliance support. 👉 Product Lifecycle Project Management Support: End-to-end support from concept development to commercialization. Services include regulatory pathway assessments, product registration assistance, and compliance monitoring. 👉 Operational Excellence: Customized strategies to optimize processes, increase efficiency, and reduce costs using methodologies like Kaizen, Lean, and Six Sigma. Contact us today for an introduction. ✉️ info@xsqgroup.com #InterimManagement #Consultancy #HR #healthcare #lifescience #medtech #medicaldevices #pharma #biotechnology #quality #regulatory #excellence #ExcellenceSquad

Do you need support of Excellence Squad during the holiday period? ✈️ Summer is fast approaching, and with it the holiday period for many of your employees. While your team is enjoying a well-deserved rest, we understand that your tasks can't stand still. We offer temporary support in various areas: 👉 Interim Management: Ensure your projects and operations continue smoothly with our experienced interim managers. 👉 Consultancy Services: Get expert advice and solutions tailored to your needs. 👉 Quality Assurance/Quality Management: We help you develop, implement, and audit robust quality management systems compliant with ISO standards for life sciences organizations. Our services include CAPA support, internal audits, supplier management, validation (CSV and Data Integrity), and quality strategy development. 👉 Regulatory Affairs: Customized regulatory strategies for pharmaceutical, biotech, and medical device companies. We handle global regulatory submissions, gap assessments, regulatory training, and ongoing compliance support. 👉 Product Lifecycle Project Management Support: End-to-end support from concept development to commercialization. Services include regulatory pathway assessments, product registration assistance, and compliance monitoring. 👉 Operational Excellence: Customized strategies to optimize processes, increase efficiency, and reduce costs using methodologies like Kaizen, Lean, and Six Sigma. Contact us today for an introduction. ✉️ info@xsqgroup.com #InterimManagement #Consultancy #HR #healthcare #lifescience #medtech #medicaldevices #pharma #biotechnology #quality #regulatory #excellence #ExcellenceSquad

Do you need support during the holiday period? ✈️ Summer is fast approaching, and with it the holiday period for many of your employees. While your team is enjoying a well-deserved rest, we understand that your tasks can't stand still. We offer temporary support in various areas: 👉 Interim Management: Ensure your projects and operations continue smoothly with our experienced interim managers. 👉 Consultancy Services: Get expert advice and solutions tailored to your needs. 👉 Quality Assurance/Quality Management: We help you develop, implement, and audit robust quality management systems compliant with ISO standards for life sciences organizations. Our services include CAPA support, internal audits, supplier management, validation (CSV and Data Integrity), and quality strategy development. 👉 Regulatory Affairs: Customized regulatory strategies for pharmaceutical, biotech, and medical device companies. We handle global regulatory submissions, gap assessments, regulatory training, and ongoing compliance support. 👉 Product Lifecycle Project Management Support: End-to-end support from concept development to commercialization. Services include regulatory pathway assessments, product registration assistance, and compliance monitoring. 👉 Operational Excellence: Customized strategies to optimize processes, increase efficiency, and reduce costs using methodologies like Kaizen, Lean, and Six Sigma. Contact us today for an introduction. ✉️ info@xsqgroup.com #InterimManagement #Consultancy #HR #healthcare #lifescience #medtech #medicaldevices #pharma #biotechnology #quality #regulatory #excellence #ExcellenceSquad

Do you need support during the holiday period? ✈️ Summer is fast approaching, and with it the holiday period for many of your employees. While your team is enjoying a well-deserved rest, we understand that your tasks can't stand still. We offer temporary support in various areas: 👉 Interim Management: Ensure your projects and operations continue smoothly with our experienced interim managers. 👉 Consultancy Services: Get expert advice and solutions tailored to your needs. 👉 Quality Assurance/Quality Management: We help you develop, implement, and audit robust quality management systems compliant with ISO standards for life sciences organizations. Our services include CAPA support, internal audits, supplier management, validation (CSV and Data Integrity), and quality strategy development. 👉 Regulatory Affairs: Customized regulatory strategies for pharmaceutical, biotech, and medical device companies. We handle global regulatory submissions, gap assessments, regulatory training, and ongoing compliance support. 👉 Product Lifecycle Project Management Support: End-to-end support from concept development to commercialization. Services include regulatory pathway assessments, product registration assistance, and compliance monitoring. 👉 Operational Excellence: Customized strategies to optimize processes, increase efficiency, and reduce costs using methodologies like Kaizen, Lean, and Six Sigma. Contact us today for an introduction. ✉️ info@xsqgroup.com #InterimManagement #Consultancy #HR #healthcare #lifescience #medtech #medicaldevices #pharma #biotechnology #quality #regulatory #excellence #ExcellenceSquad

Do you need support during the holiday period? ✈️ Summer is fast approaching, and with it the holiday period for many of your employees. While your team is enjoying a well-deserved rest, we understand that your tasks can't stand still. We offer temporary support in various areas: 👉 Interim Management: Ensure your projects and operations continue smoothly with our experienced interim managers. 👉 Consultancy Services: Get expert advice and solutions tailored to your needs. 👉 Quality Assurance/Quality Management: We help you develop, implement, and audit robust quality management systems compliant with ISO standards for life sciences organizations. Our services include CAPA support, internal audits, supplier management, validation (CSV and Data Integrity), and quality strategy development. 👉 Regulatory Affairs: Customized regulatory strategies for pharmaceutical, biotech, and medical device companies. We handle global regulatory submissions, gap assessments, regulatory training, and ongoing compliance support. 👉 Product Lifecycle Project Management Support: End-to-end support from concept development to commercialization. Services include regulatory pathway assessments, product registration assistance, and compliance monitoring. 👉 Operational Excellence: Customized strategies to optimize processes, increase efficiency, and reduce costs using methodologies like Kaizen, Lean, and Six Sigma. Contact us today for an introduction. ✉️ info@xsqgroup.com #InterimManagement #Consultancy #HR #healthcare #lifescience #medtech #medicaldevices #pharma #biotechnology #quality #regulatory #excellence #ExcellenceSquad

👉 Krishna reddy Mogulla Quality Assurance Manager | Lean Six Sigma, Quality Management, Operational Excellence, Regulatory Affairs, Compliance | B.Pharm, M.Tech, MBA | Novartis healthcare, Ashland inc, Natco Pharma | 🔗 Let's connect with Krishna Reddy Mogulla 😊 | Like | Comment | Repost | Send | Personal Branding: Broadcast message #krishnareddymogulla

Things to consider if you want to work or collaborate with Pharma Industry   Regulated by: ✅Ministry of Health or delegated local authorities ✅WHO Standards ✅Pharma Associations (PhRMA, EFPIA, PHRMAG..) ✅Internal Compliance Procedures ✅All other country laws (applicable to all business subjects)   Supply Chain: ☑Complex supply chain across multiple locations, from API to finished forms ☑Storage & distribution, from ambient to cold chain, to ultra-low temperatures of -90°C ☑From simple chemical molecules to complex biologics, to toxins and opioids that require special import permits ☑Country / Region specific product labels and shelf life in between few weeks to few years   Highly Specialized Departments: ▶Regulatory – a team that is in charge of product registration and quality controls. Their skills are crucial, especially if you want to achieve an accelerated yet compliant product launch. ⚕Medical – a team that leads clinical trials, scientific HCP engagements and awareness campaigns. Lately they are more frequently in charge of internal compliance and patients’ programs.   ♻Market Access – a team in charge of early access programs, price calculations and reimbursement negotiations. Usually, they are the first to know what is happening on the market. ➰Patient Support – this team will collaborate with multiple stakeholders to improve patient experience. Some products will require multidisciplinary approach of healthcare professionals to minimize side effects and improve efficacy.   Sales & Marketing Department: ✅Most of the registered pharma products can’t be promoted on mainstream media 📅Marketing activities are usually built around the scientific agenda of a particular symposium that aims to increase participants' knowledge, expose them to the burden of disease, and provide therapeutic options / solutions 📈Sales teams will be focused on share of voice (SOV) metrics and In Market Sales (IMS) 🔍Customer Excellence – teams would provide training support to Sales teams and track their performance via specific KPIs Supporting Functions: 🚻HR – is in charge of compensation & benefits policies, would provide a platform for goals setting and measurement of achievements. They should provide a strategical balance between management and employees, securing adequate supply of talents to organization and leading initiatives such as DEI. 💰Finance – should ensure that plans are executed, company cash flow is sufficient and risk controls are adequate. Their routine job would require detailed analysis of journals / results and providing strategic insights to model future scenarios. Finance has an important role to drive accountability, transparency, and efficiency in the organization. 📃Legal & Compliance – this team will ensure that cooperation with external parties is done in a compliant and sustainable way. They will safeguard the company from internal and external risks.   What did I miss? What are the specifics of your industry? #pharmaceutical #UAE