At Synaptis, we offer three flexible models to meet our clients’ needs. First, through staff augmentation,
we provide individual experts who complement a client’s project, allowing them to retain full control while benefiting from specialized support.
Second, with our managed services model, we supply a multi-disciplinary team that not only complements the client’s project but also assumes responsibility based on defined KPIs, ensuring a collaborative, results-driven approach.
Finally, with our project based model, Synaptis takes full ownership of delivering a product or service, guaranteeing outcomes and allowing the client to focus on other priorities while we ensure success.
Commissioning, Qualification, Validation
We assist with commissioning, qualification and validation activities (CQV) to ensure equipment, processes, and systems meet regulatory requirements and quality standards.
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Synaptis provides comprehensive CQV services to ensure life sciences equipment, processes, facilities and systems meet the highest regulatory and operational standards. From initial commissioning to qualification and validation, we support clients in verifying that equipment, processes, and systems are fully compliant with industry regulations like GMP and FDA.
Our team delivers expertise in protocol development, execution, and documentation, ensuring smooth project delivery and regulatory approval. With a focus on precision and compliance, we help clients maintain product quality and operational integrity.
We assist with:
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Cleaning validation
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Sterilization validation
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Process validation
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Equipment qualification
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Computer system validation
Process Engineering
For efficiency, compliance, and innovation, we help to optimize and streamline manufacturing processes for pharmaceuticals, biologics, medical devices, and other life science products.
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We help optimize and streamline manufacturing processes for pharmaceuticals, biologics, medical devices, and other life science products. This includes process design, scale-up, troubleshooting, and validation to ensure efficiency and compliance.
From process design and scale-up to troubleshooting and regulatory support, our team provides tailored solutions that streamline operations, reduce costs, and improve product quality.
Whether it is implementing automation, ensuring GMP compliance, or driving sustainable practices, we work closely with our clients to deliver real results that align with their business goals.
Quality Engineering
At Synaptis, we support quality management systems by developing and implementing quality assurance procedures, conducting risk assessments, and facilitating continuous improvement initiatives.
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We provide support in quality engineering to help life sciences companies maintain the highest standards of product quality and regulatory compliance. Our services include quality system design, process validation, risk management, and compliance with industry regulations such as GMP and FDA requirements.
We assist in implementing effective quality controls, performing audits, and resolving deviations to ensure your products meet both safety and performance standards.
Regulatory Compliance
We help life science companies navigate regulatory requirements and ensure compliance with regulations such as FDA, EMA, and ISO standards.
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Navigating regulatory requirements is essential for life science companies to ensure patient safety, gain market approval, and maintain product quality. Compliance with standards set by agencies like the FDA, EMA, and ISO is critical for protecting public health, avoiding costly legal issues, and ensuring products are safe and effective. It also enables companies to bring their products to market faster and maintain trust with both regulatory bodies and consumers.
We help life science companies navigate regulatory requirements and ensure compliance with regulations such as FDA, EMA, and ISO standards. This includes offering guidance on regulatory submissions, conducting gap assessments, and preparing for regulatory inspections.
Product Development
With our engineering expertise, we support product development by offering design, prototyping, and testing services for medical devices, pharmaceutical formulations, and biotechnology products.
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Our goal is to assist life sciences companies in bringing innovative products to market with speed and precision. With our know-how in engineering, we support product development efforts by providing expertise in optimizing product design, prototyping, testing services, ensuring compliance with industry standards, managing project timelines efficiently for medical devices, pharmaceutical formulations, and biotechnology products.
With a focus on innovation and quality, we help clients navigate complex development challenges and deliver successful products that meet market needs and regulatory requirements.
Packaging Engineering
We offer packaging design and optimization services to ensure life science products are safely and effectively packaged for storage, transportation, and distribution.
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Effective packaging design and optimization are crucial for life science products because they ensure the safety, stability, and integrity of sensitive items like pharmaceuticals, biologics, and medical devices. Proper packaging protects products from contamination, physical damage, and environmental factors during storage and transportation.
It also ensures regulatory compliance by meeting stringent industry standards for safety and labeling. Optimized packaging can streamline distribution, reduce costs, and improve efficiency throughout the supply chain, while safeguarding product quality from manufacturing to the end-user.
We offer packaging design and optimization services to ensure life science products are safely and effectively packaged for storage, transportation, and distribution. Our goal is to protect product integrity while enhancing efficiency throughout the supply chain.
Training
We provide training and educational programs to help life science professionals develop skills and knowledge in areas such as engineering best practices, regulatory compliance, and new technologies.
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Training and educational programs are vital for life science professionals to stay current with engineering best practices, regulatory compliance, and emerging technologies. This helps ensure they can effectively implement industry standards, maintain compliance, and adapt to evolving innovations, which enhances both individual expertise and organizational success.
Automation and control systems
We help develop and implement automation solutions to improve efficiency, consistency, and reliability in manufacturing processes. This includes control system design, programming, and integration of instrumentation and equipment.
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Developing and implementing automation solutions is essential for improving the efficiency, consistency, and reliability of manufacturing processes. By designing, programming, and integrating control systems and equipment, automation reduces human error, enhances productivity, and ensures consistent product quality. It also helps streamline operations and optimize resource use, contributing to overall operational effectiveness.
Facility/utility Engineering
We provide expertise in designing, constructing, and maintaining facilities that comply with regulatory requirements for Good Manufacturing Practices (GMP) and other industry standards.
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Designing, constructing, and maintaining GMP-compliant facilities is crucial for ensuring product quality, safety, and regulatory compliance, particularly in industries like pharmaceuticals and food production.
These facilities help prevent contamination, streamline operations, and minimize human error, while adhering to strict environmental controls. Compliance with GMP is also essential for avoiding regulatory penalties and gaining global market access.
