Welcome To
BIMAG Solutions Portfolio
“We operate at both the strategic, architectural level, and at the tactical, quality and compliance sub-system level ensuring your compliance outcomes are exceptional, from top to bottom.” From workforce planning to employment value proposition ,talent strategy and technology, we help companies address critical needs and apply best –practice solutions”
Organization Portfolio – Value-driven clients solutions in Middle East region includes;
1. Regulatory Intelligence / Strategy for expansion into new markets.
2. CTD Files’ conversions and eCTD publishing, with Licensed Application of Hardware / Software Requirements Dossier Mgmt.
3. CTD Conducting Training Sessions & Workshop with Licensed Legal Certification. We have our International Licensed Experts to conduct such training.
4. Pharmacovgiliance services. We have our International Expertise providing support services right from setting up PSMF, training our Local Safety Responsible (LSR), Operational support from case processing, Writing of RMP, PSUR, and Signal detection for our marketed products.
5. Consulting support, including Scientific advice / Consulting with health authorities for establishing launch strategy / market.
6. Providing many training topics (Class lessons Learnt) in-house or in client venue pertaining to Business, Marketing Qualifications / Requirements such as; Export management, and that pertaining to Quality systems such as; GMP.
7. On a way for conducting a lot of training sessions pertaining to Environment, Health, Safety, and Stability (EHSS). Meanwhile; for auditing EHSS functions and facilitating readiness for Pharmaceutical and Food Industries companies, with third party audits and QA / Compliance
Consulting.
8. On a way to support pharmaceutical facilities to acquire EHSS_ ISO and NEBOSH Certifications – Materials are under preparation.
9. On a way to Provide Full Regulatory Systems’ Portfolio such as; Performance Indicator Program (PIP), Validation, Bioequivalent, and Stability Study.
10. On a way to Provide our clients by Quality Management Systems such as; Risk Assessment System, Crises Management, Emergency Preparedness Management System, and Business Continuity Plan.
تنهض جميع شركات الدواء المصرية للتصدير للخارج للنهوبض بالمنظومة الدوائية وتشجيع استثمارات صناعة الدواء ، وللنجاح فى التصدير يجب على جميع أقسام الشركات الألمام بتطبيق نظام التسجيل الموحد العالمى ، وتحضير ملفات التسجيل الخاصة بالمستحضرات الدوائية طبقا للنظام العالم
لذلك .. نحن نقدم لعملائنا المصريين والعرب والأجانب خدماتنا فى هذا الشأن ، والمتضمنة تسجيل المنتجات
الدوائية وةالمستحضرات الحيوية والمكملات الغذائية ، والمستحضرات البيطرية وعمل عقود التصنيع لدى الغير مع المصانع المرخصة للتصنيع
ترخيص وأعتماد المصانع المصرية والعربية ومراكز دراسات الثبات والتكافؤ الحيوى
دراسات الثبات والتكافؤ الحيوى منفذه DMF للأدوية البشرية كاملة شاملة eCTD–CTD توفير ملفات
تقديم خدمات اليقظة الدوائية بواسطة شركاتها من الشركات العالمية مع عمل دورات تدريبية بواسطة مدربين معتمدين ، كمسؤلى اليقظة الدوائية
عمل البرامج التدريبية المعتمدة مرفقق بيانها للصيادلة والكميائيين والمهندسين والفنيين ، واصدار الشهادات المعتمدة لذلك.
Our mission is to provide a strong foundation of professional counseling to all our customers whether organizations or individuals through:
- Training & Consulting.
- Marketing.
- Promotional support services.
We have a very strong commitment to all our valued customers whether international corporations, small businesses or individual customers:
- Customer Satisfaction
- Integrity and Positive change.
- Product continuity and availability.
EHS and ISO
GMP strategy and development.
eCTD software training & implementation.
Objectives
Our objective is to establish a comprehensive organization for the Middle East / Africa(MEA) region to effectively cover multiple markets in:
- CTD registrations.
- GMP strategy and development.
- eCTD software training & implementation.
- EHS and ISO
Company staff
- Our Expert Staff seek to provide all of our clients with the highest levels of service and professionalism.
- Our consultants are professionals trained to recognize your requirements and provide you with only the most relevant and up to date resources so as to help you to concentrate on achieving your goals.
- Our strength lies in our insight and understanding of your business needs providing you with a range of solutions to fluctuating market demands, evolving business strategies and changing work force need.