Quality assurance services for the entire product development lifecycle

Achieve top-tier accuracy and efficiency at every stage of your product development lifecycle with our Quality Assurance services. We are committed to helping you meet stringent regulatory standards and maintain high-quality outcomes, minimizing risks and enhancing product integrity.

Enhance QA with expert consulting

Our Quality Assurance solutions provide comprehensive support to uphold product quality and regulatory compliance. With expert guidance and advanced tools, we ensure seamless adherence to quality standards from internal audits to process optimization. Explore the features below to see how our QA services elevate your quality management processes.

Ensure consistency and compliance across operations

  • Develop and implement Standard Operating Procedures (SOPs) and guidelines
  • Create robust document management systems for accurate and accessible documentation
  • Maintain compliance with industry standards and regulatory requirements

Enhance skills and drive continuous improvement 

  • Design and deliver targeted training programs using workshops, webinars, and e-learning
  • Implement systems to gather and analyze customer and employee feedback
  • Use insights to drive improvements and enhance satisfaction

Identify risks and ensure regulatory adherence

  • Conduct comprehensive risk assessments at organizational, project, and process levels
  • Perform audits for GMP, GCP, GVP, GLP, and 21CFR Part 11 compliance
  • Prepare for inspections and maintain readiness with thorough audits

Drive quality through ongoing enhancements

  • Develop and support continual improvement programs and trend analysis.
  • Monitor and measure product and service quality, addressing deviations promptly.
  • Implement Corrective and Preventive Actions (CAPA) to manage non-conformities.

Ensure resilience and preparedness

  • Support Business Continuity Planning (BCP) and Disaster Recovery (DR) strategies
  • Conduct planning and testing to validate recovery processes
  • Minimize disruption and ensure readiness for unforeseen events

why synapmed?

Synapmed offers cutting-edge AI, intelligent automation and workflow, and advanced analytics technology solutions to optimize every phase of your clinical development and commercialization.

Our comprehensive approach integrates pharmacovigilance as a service (PVaaS), system implementation, and business advisory services to streamline drug safety and data management. From initial setup to ongoing support, we leverage data-driven insights to accelerate trials, ensure compliance, and improve outcomes.

Our expert advisory and efficient project delivery services help reduce costs, enhance compliance, and meet your business goals with ease.

Frequently asked questions

What are Quality Assurance services?
Quality Assurance (QA) services encompass a systematic approach to ensuring that products and services meet established quality standards throughout the product development lifecycle. This includes developing and implementing Standard Operating Procedures (SOPs), conducting risk assessments, managing documentation, and performing audits to maintain product integrity and regulatory compliance.
Quality Assurance in product development ensures accuracy and efficiency at every stage. It includes developing and implementing Standard Operating Procedures, managing documentation, conducting risk assessments, and performing compliance audits to meet regulatory standards and maintain product integrity.
Regulatory compliance in R&D is achieved through stringent adherence to industry standards. This involves conducting comprehensive risk assessments and audits to ensure that research and development processes meet all regulatory requirements.
SOPs are detailed, written instructions that ensure consistency and compliance in processes. They are crucial for maintaining quality control, ensuring that all team members follow the same procedures, and meeting regulatory standards across operations.
Document management involves creating and maintaining robust systems for handling and storing documents. This ensures that all documentation is accurate, accessible, and compliant with industry regulations, supporting overall quality management efforts.

Training is essential for enhancing skills and ensuring that staff are knowledgeable about quality standards and procedures. Effective training programs, including workshops and e-learning, help drive continuous improvement and maintain high-quality outcomes.

Risk assessments involve evaluating potential risks at organizational, project, and process levels. This process helps identify vulnerabilities, assess their impact, and implement strategies to mitigate risks and ensure compliance with regulatory requirements.

Compliance audits assess adherence to regulatory standards and internal procedures. They include reviewing processes and documentation to ensure they meet required guidelines, and preparing for inspections to demonstrate compliance.
Continual improvement involves ongoing efforts to enhance processes and address quality issues. It includes monitoring product and service quality, analyzing trends, and implementing Corrective and Preventive Actions (CAPA) to manage non-conformities and drive improvements.

BCP involves developing strategies to ensure operational resilience in the face of disruptions. This includes planning and testing recovery processes to minimize impact and ensure that the organization can continue functioning effectively during unforeseen events.

Synapmed’s QA services provide comprehensive support, including SOP development, risk assessment, and compliance audits. Our expert team ensures that all processes meet regulatory standards and that quality management systems are effectively implemented, supporting your product development goals.

What is the Right Outsourcing Strategy for Your Company? Not One Model Fits All

Pharmacovigilance (PV) is crucial for the pharmaceutical and biotech industries as safety regulations grow increasingly complex. Companies encounter challenges in managing rising data volumes, resulting in higher costs and a need for specialized expertise. In response, many organizations are outsourcing PV functions to cut costs and tap into expert knowledge. Successful outsourcing hinges on careful partner selection aligned with specific needs, while retaining essential tasks in-housed when necessary. By effectively managing these partnerships, companies can navigate the complexities of pharmacovigilance while concentrating on their core competencies.

Dedicated to youR Project

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. A team that listens, pays attention to details, and brings smart insights to the table. All so you can solve real problems throughout the product development and commercialization lifecycle.