SEN Pharma is a leading provider of contract research organization (CRO), training, and consulting in EU-GMP, GSP, GDP, lean manufacturing, and pharmaceutical quality management system improvement. We are committed to contributing to the development of a robust Vietnamese pharmaceutical industry that meets international standards.
SEN Pharma offers a comprehensive suite of services to meet the needs of pharmaceutical manufacturers.
1. Contract Research Organization (CRO):
- Tailored research and development services to meet client-specific needs.
- A team of experienced professionals ensures high-quality research conducted within timelines and budgets, adhering to scientific and ethical principles.
- Guaranteed product stability within the shelf life and successful technology transfer.
- Detailed bilingual research documentation for domestic and international product registration.
- Customized solutions for each business, ensuring efficiency and cost-effectiveness.
2. EU GMP Consultancy:
- Comprehensive consulting from design, construction, validation to quality systems, product registration, and distribution in Europe.
- Being exclusive representative of KIPA (Austria), a highly experienced consultant with successful EU-GMP inspections and re-inspections of many factories in Southeast Asia and Asia.
- Support for product registration and distribution in Europe with large volumes, guaranteeing sales in the first three years.
- Customized solutions for each business, ensuring efficiency and cost-effectiveness.
3. Training:
- In-depth training courses in various areas of the pharmaceutical industry, such as research and development, quality management, lean manufacturing, regulations, and technical English, to enhance employees’ expertise and improve work performance.
- Well-structured training programs closely aligned with practical applications and the latest pharmaceutical knowledge.
- A team of reputable lecturers with extensive practical experience and excellent communication skills ensures effective knowledge transfer.
4. Registration:
- Consulting on the registration of domestically manufactured or imported drugs and supplements, helping companies save time and costs and launching product quickly.
- A team of consulting experts with a deep understanding of product registration regulations, supporting businesses in preparing complete dossiers that meet regulatory requirements.
- Monitoring registration progress, reporting results, and assisting in resolving any issues that arise.
5. Specification & Analytical method:
- Consulting on the development of specifications and analytical methods for products.
- Optimizing analytical processes and resolving deficiencies in assay testing, leading to increased active ingredient overage.
- Validating analytical method, supporting the analysis of test results, and investigating OOS and OOT.
- Preparing detailed and completed bilingual analytical reports.
6. CSV (Computer System Validation):
- Validating and ensuring the validity of computer systems in pharmaceutical production, optimizing processes and minimizing risks.
- A team of experienced CSV experts applying scientific methods and advanced technologies to conduct efficient validations.
- Providing detailed validation reports with complete information to help companies effectively manage their computer systems.
7. Quality System Enhancement:
- Improving and enhancing quality management systems for manufacturing plants, ensuring consistency and efficiency in production operations.
- Assessing the current quality management system, identifying areas for improvement, and proposing appropriate solutions.
- Supporting businesses in implementing improvement solutions, monitoring effectiveness, and making adjustments as needed.
A Professional and Dedicated SEN Pharma Team
Led by Mr. Vo Le Ngoc Chau, a Master of Pharmacy, with over 10 years of practical experience in the pharmaceutical manufacturing industry, SEN Pharma boasts a team of highly qualified employees with a professional and dedicated work style. .
Committed to developing with four core values of “Professionalism – Dedication – Creativity – Revolutionary”, SEN Pharma strives to become a trusted partner for pharmaceutical manufacturers in Vietnam.
