Your One-Stop Solution for Pharmaceutical Manufacturing
In this era of AI, pharmaceutical engineering plays a crucial role in optimizing processes, enhancing efficiency, and ensuring regulatory compliance throughout the drug development and manufacturing lifecycle. With the advent of advanced technologies such as artificial intelligence, data analytics, and automation, pharmaceutical companies have unprecedented opportunities to innovate and streamline their operations.
What We Do
At Saraca, we are committed to driving progress in the pharmaceutical sector by leveraging our expertise in engineering and digital technologies. Here's how we contribute to our customers in this sector:
1. Process Optimization: We harness the power of digital tools and analytics to optimize pharmaceutical manufacturing processes, minimizing waste, reducing cycle times, and maximizing yield.
2. Quality Assurance: Our rigorous quality assurance practices and advanced monitoring systems ensure that pharmaceutical products meet stringent regulatory requirements and adhere to the highest quality standards.
3. Technology Integration: We integrate cutting-edge technologies such as IoT sensors, predictive modeling, and real-time monitoring systems into pharmaceutical facilities to enable data-driven decision-making and proactive maintenance.
4. Innovation and R&D: We collaborate with pharmaceutical companies to drive innovation and accelerate the development of novel drug delivery systems, formulations, and manufacturing processes, bringing life-changing therapies to market faster and more efficiently.
5. Sustainability and Environmental Stewardship: We are committed to promoting sustainable practices in the pharmaceutical industry, helping our customers minimize their environmental footprint and embrace eco-friendly manufacturing processes.
6. Compliance and Regulatory Support: We provide comprehensive support to ensure regulatory compliance at every stage of the pharmaceutical lifecycle, helping our customers navigate complex regulatory landscapes with confidence.
Pharmaceuticals Segments
Quality Assurance, QMS and Data Integration
- Design quality including GMP and GDP
- Equipment qualification (IQ/OQ/PQ)
- Process validation (OSD/LD/SVP)
- Implementation of new regulations into existing QMS
- Preparation of external audit
- CAPA procedure management and risk management
- Investigation and root cause analysis (RCA)
- Internal and Lead Auditor
- ICH Q9: Quality Risk Management
- Regulatory Compliance per WHO, USFDA, SAHPRA, MHRA, TGA, Health Canada and EMEA
Regulatory Affairs
- Global regulatory strategy
- Dossier gap analysis & remediation
- CMC writing & regulatory documentation review
- Compliance with ICH guidelines
- Regulatory dossier preparation and compilation for new product registration (CTD, ACTD)
- Computer system validation (CSV) per US FDA 21 CFR Part 11 and Canadian requirements
- Resolution for FDA 483
Quality Remediation and Compliance Verification
- Revised QMS documents (Change control, Deviation, Investigation, OOS and CAPA procedure)
- Revised compliance verification procedure
- Gap assessment of current procedures with FDA requirements.
- Implementation of procedures and effectiveness verification
- Facility remediation
- Facility modification and documentation (HVAC qualification)
- Facility qualification and temperature mapping
- Aseptic technique SOP
Our Service Offerings
Conceptual Design and Feasibility Studies
From initial concept to feasibility analysis, we offer comprehensive services to help you define and refine your pharmaceutical projects with precision and foresight.
Process Engineering
Our team of seasoned engineers excels in designing, optimizing, and implementing pharmaceutical processes to ensure efficiency, compliance, and product integrity throughout the production lifecycle.
Equipment Selection and Validation
Leveraging our expertise and industry insights, we assist in selecting the most suitable equipment and validating their performance to meet the stringent regulatory requirements of the pharmaceutical sector.
Facility Design and Commissioning
Whether it's the design of a new facility or the renovation of an existing one, we provide end-to-end solutions for facility design, commissioning, and qualification to meet the highest standards of safety, functionality, and compliance.
Regulatory Compliance and Documentation
Stay ahead of regulatory challenges with our specialized services in compliance assurance and documentation management, ensuring that your pharmaceutical operations adhere to global regulatory standards.
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About Us
SARACA is a rapidly growing product engineering services company with deep expertise in digital, artificial intelligence, and emerging new technologies. Founded in 2014, SARACA is powered by Gen Z and Millennials with greater focus on agility, customer centricity, faster technology adoption, and adherence to cultural sensitivity. Our digital natives perform their actions with speed and ensure that we exceed customer expectation every single time. SARACA adopted vertically integrated approach to build depth in the industries we operate in. Over the years we have built strong expertise in aerospace, defense, space, automotive, medical devices, Industrial, Farm Equipment, rail transportation, technology, semiconductor, and many other industries.
