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- About MC Pharma: Your Regulatory Pharmaceutical Company
Your Trusted Regulatory Pharmaceutical Company Pioneering Regulatory Excellence Prioritizing Patient Safety and Regulatory Compliance Embark on a journey with MC Pharma, a regulatory pharmaceutical company dedicated to steering your health products through the complex regulatory landscape in Africa. Our Mission MC Pharma serves as a reliable connection between pharmaceutical innovation and the global market, providing proactive assistance in a constantly evolving international landscape. We prioritize healthcare excellence, respect, and diversity, fostering collaboration and innovation for timely medication access and healthcare advancement. Simplifying Regulatory Complexities Our Vision Our commitment is to safeguard and enhance patient health by consistently delivering pharmaceutical products and services of the highest quality, ensuring safety and efficacy that meet global customer expectations. We achieve this through the implementation of current good manufacturing practices, cutting-edge technology, a skilled workforce, and efficient management practices. Fostering Growth Our Story About Us Global Footprint MC Pharma has over 25 years of regulatory experience. From being part of the genesis of a number of industry associations, to being at the forefront of regulatory legislative changes, MC Pharma has been intimately involved in every aspect. MC Pharma staff boasts experience in Retail Pharmacy, Hospital and the Research spheres of the pharmaceutical industry. A strong background in Academia is also reflected in MC Pharma’s diligent regulatory processes. We pride ourselves in being at the cutting edge of international regulatory changes to assist our customers pro-actively adapt to the ever changing requirements and regulations. Paired with extensive knowledge of the pharmaceutical industry as a whole, from SAHPRA (South African Health Products Authority) submissions to business growth and management, MC Pharma can adapt to the dynamic needs of the client. We endeavor to find innovative solutions to any aspect of the pharmaceutical regulatory process, and to assist our clients reach their goals in a dynamic international market. MC Pharma (Pty) Ltd., is a specialist pharmaceutical company licensed in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965, and offers the services of an Applicant and Holder of the Registration Certificate (Marketing Authorisation Holder), on behalf of a Principal or Product Owner. MC Pharma has a combination of local licenses (DoH, SAPC, SAHPRA) thereby enabling us to act as contract Marketing Authorisation Holder (MAH) and local SAHPRA liaison on behalf of a principal or product owner. Services offered: Regulatory Intelligence Sales and Marketing Section 21 Application Import and Exports New Business Development MC Pharma has, in addition to our local Clients, a wealth of global Clients in countries such as the UK, Australia, France, Germany, Brazil, China, India, Israel, China, and the USA. We endeavor to find innovative solutions in an ever-changing international market to assist our clients in reaching their goals. MC Pharma has a national sales footprint and we cover the entire African market (South Africa, Namibia, Lesotho, Botswana and Swaziland), as well as most countries upon inquiry. MC Pharma distributes through outsourced Distributors and Wholesalers. We have long-standing and trusted, pre-approved, relationships with reputable Distributors and 2 Wholesalers in Africa. Company Profile Upholding Regulatory Standards Immerse in MC Pharma’s profile, reflecting a robust foundation in regulatory affairs, market analysis, and strategic partnerships, all tailored to ensure your successful market entry. Form Partnership We are dedicated to delivering high-quality products and services. 01 We uphold unwavering integrity in all our actions. 02 We firmly believe in transparent and open communication. 03 We are staunch advocates for the empowerment of our people, fostering entrepreneurship, innovation, and accountability. 04 We actively practice non-discrimination and provide equal opportunities for all. 05 We hold profound respect for individuals, society, and the environment. 06 Our Values What We Stand For Tracy Burger Executive Chairman of the Board Junita Castle Executive Finance and Logistics Jaco Van Der Wath Executive Sales and Marketing Declan Burger Executive Compliance Meet The Executive Team Committed to Excellence Our values of integrity, innovation, and partnership remain the compass that guides our actions, fostering a culture of trust, adaptability, and collaborative growth. Connect With Us Your Product Success, Our Priority Get in touch with our team of seasoned professionals to discuss how MC Pharma can accelerate your regulatory compliance and market entry journey in Africa. Meet The Team Our Employees Our employees constitute our most valuable asset. We hold in high regard the unique creativity of each individual employee and cultivate an environment that aligns with our core values. The Team Our Customers Our commitment is to surpass the requirements and expectations of our customers in terms of value, quality, and service through our products and services. We aim to instill confidence in our customers by consistently being a fair and reliable partner. Surpass Expectations
- Member Page | MC Pharma New v5
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- Adverse Drug Reactions | MC Pharma
Comprehensive Management of... Adverse Drug Reactions Prioritizing Patient Safety and Regulatory Compliance Adverse Drug Reactions (ADRs) are a critical concern in the pharmaceutical industry. MC Pharma places paramount importance on understanding, managing, and reporting ADRs to ensure patient safety and adhere to regulatory standards for products registered on our license. Stay Informed, Stay Safe Contact us to report products registered under our license Reach out to MC Pharma for expert guidance on Adverse Drug Reaction management. Our dedicated team is ready to assist you in navigating the complexities of ADR reporting and management, ensuring a safer pharmaceutical practice. Adverse Drug Reaction Form What Are Adverse Drug Reactions? The Implications of ADRs in Pharmaceutical Operations An adverse drug reaction is an unwanted or harmful reaction experienced following the administration of a medicine. Understanding the types, causes, and implications of ADRs is crucial for ensuring patient safety and regulatory compliance. Learn More Adverse Drug Reaction Assistance Form Adverse Drug Reaction Assistance Form for products registered on MC Pharma’s license First name* Last name* Email* Phone Product Name* Are you currently experiencing a reaction?* Yes No Please explain in as much detail as possible what reaction you are experiencing and what you think caused it.* Submit Reach Out For Assistance FAQ's What are adverse drug reactions? ADRs are unwanted, uncomfortable, or dangerous effects that drugs may have . They can be considered a form of toxicity . ADRs can occur due to overingestion (accidental or intentional) or to elevated blood levels or enhanced drug effects that occur during appropriate use . How do companies monitor adverse drug reactions? Companies monitor ADRs through various methods including formal drug safety studies, published data, pharmaceutical company data from periodic safety update reports (PSURs), and shared international data . They also use specific investigations and laboratory tests . What is the process to report an adverse drug reaction? The process to report an ADR involves healthcare professionals or patients reporting suspected adverse reactions to regulatory bodies . This can be done via specific software, email, fax, or post . How do adverse drug reactions impact drug approvals? ADRs can impact drug approvals as negative results are less likely to be published than positive results . Regulatory bodies may require additional information to establish the safety, quality, and efficacy of medicines . What are the most common adverse drug reactions reported? Common ADRs include upset stomach, dry mouth, and drowsiness . Digestive disturbances such as loss of appetite, nausea, bloating sensation, constipation, and diarrhea are also common . How can patients avoid adverse drug reactions? Patients can avoid ADRs by keeping a list of their medicines, following directions, asking questions, keeping up with any blood testing recommended by their doctor, and taking all medicines only as directed . What role do healthcare professionals play in monitoring adverse drug reactions? Healthcare professionals play a key role in monitoring ADRs. They are best placed to report suspected adverse reactions as part of patient care . How do regulations ensure the reporting of adverse drug reactions? Regulations ensure the reporting of ADRs by requiring manufacturers of prescription medical products to submit adverse event reports to regulatory bodies . Regulatory bodies may also request any additional information to establish the safety, quality, and efficacy of medicines . What are the challenges in monitoring adverse drug reactions? Challenges in monitoring ADRs include the increasing complexity of therapeutics, an ageing population, rising multimorbidity , and issues with pharmacovigilance systems such as lengthy and complicated reporting forms . How do companies ensure the safety of their drugs post-adverse reactions? Companies ensure the safety of their drugs post-ADRs through periodic, unannounced inspections of drug production and control facilities . If a drug has the potential for serious adverse effects, regulatory bodies may require that the manufacturer establish a Risk Evaluation Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks .
- Pharmaceutical Regulatory Services in South Africa | MC Pharma
Your Trusted Partner in Africa Market Entry to Market Leadership Navigating Regulatory Paths, Building Market Leadership A seamless journey, with MC Pharma, your partner in sales, marketing and tenders in Africa Book Consultation Our affiliations from reputable bodies affirm our competence and commitment to adhering to the highest standards of regulatory compliance. Our Affiliations MC Pharma is a specialist pharmaceutical company, adept in navigating the complex regulatory environment, ensuring that products meet the stringent compliance requisites of African markets. Who We Are Expertise Rooted in Experience Learn More From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations. Tailored for Your Success Our Service Spectrum All Services Regulatory Intelligence Regulatory Consulting and Quality Assurance Sales and Marketing We have a passionate and innovative Sales & Marketing Team that delivers a spectrum of services Import & Export Services Distribution and Wholesale New Business Development Business Development Services Our Products Suite Compliant, Reliable, and Market-Ready Explore our range of products, each engineered to meet the rigorous regulatory standards of the pharmaceutical landscape in South Africa. Our Products Medical Products Explore our range Medical products already approved for South African market. Our Products Industry Insights Stay Updated, Stay Ahead Dive into the latest updates and trends in the pharmaceutical industry to keep your operations compliant and competitive. All Articles Adverse Drug Reaction Reporting Ensuring Patient Safety Report adverse drug reactions promptly, aiding in the continuous effort to uphold patient safety and product efficacy. Approach ADR's Correctly Connect With Us Your Success, Our Priority Reach out to our team of seasoned professionals to discuss how MC Pharma can facilitate your pharmaceutical market entry and compliance journey in Africa. Contact Us Our Partners Collaborative Growth Meet our global partners who have leveraged MC Pharma’s expertise for successful market entry and regulatory compliance in Africa. Partners Our Global Footprint International Collaborations Beyond our local partnerships, MC Pharma is also connected with a network of global partners, expanding our reach and capability in delivering comprehensive pharmaceutical solutions across borders. Become Global
- Industry News | My Site 5
Latest Insights and Updates Pharmaceutical Regulatory News Your Trusted Source for Pharmaceutical Regulatory News Explore a wealth of Pharmaceutical Regulatory News, encompassing policy changes, regulatory advancements, and industry trends, curated meticulously to provide you with a reliable source of latest updates. Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Find Topics of Interest Easy Navigation Through Regulatory News Utilize our categorized and searchable news database to find specific topics or regulatory updates of interest, making it easier to access the information you need. Never Miss an Update Stay informed and ahead in your field by subscribing to MC Pharma’s news feed. Receive the latest Pharmaceutical Regulatory News directly in your inbox, ensuring you never miss an important update. Subscribe to Our News Feed First name* Last name* Email* Stay Connected Have Questions? Reach Out to Our Regulatory Experts For any inquiries or further clarification on Pharmaceutical Regulatory News, feel free to contact our regulatory experts. We are here to assist and provide the insights you need. Contact Us
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News Title 05 News Title 05 28/02/23, 22:00 This is a paragraph. It is connected to a CMS collection through a dataset. Click “Edit Text” to update content from the connected collection. This is a paragraph. It is connected to a CMS collection through a dataset. Click “Edit Text” to update content from the connected collection. Previous Next