Ensuring The Safety And Efficacy Of Products
Helix Life Sciences is a leading provider of quality management services for pharmaceutical and medtech companies. We help our clients achieve and maintain compliance with the highest quality standards, ensuring the safety and efficacy of their products.
- Our Capabilities
Compliance Development Plans
QMS Expertise
Helix Life Science excels at developing and implementing robust QMS systems that align with industry-specific regulations and client-specific needs.
QP/PRRC Guidance
Helix Life Science provides expert QP/PRRC services to ensure compliance with stringent quality standards and safeguard product integrity.
Comprehensive Quality Strategies
Helix Life Science formulates tailored quality strategies aligned with business goals, driving continuous improvement and enhancing product quality across both industries.
- Client Goals
Tailored Quality Solutions for the Life Sciences Industries
Implement robust QMS systems and achieve compliance with stringent regulations to guarantee product safety and efficacy.
Leverage expert QP/PRRC services to navigate complex regulatory requirements and ensure product quality.
Develop comprehensive quality strategies aligned with business goals to enhance overall product quality and performance.
Our comprehensive range of services target to the pharmaceutical and medical device industries, encompassing:
Quality Management Systems
Developing and implementing robust Quality Management Systems (QMS)for both pharmaceuticals and medical devices, ensuring alignment with respective regulatory requirements and specific needs of each industry.
Providing Qualified Person
Providing Qualified Person (QP/PRRC) services across both industries, including pharmaceutical and medical devices, to ensure products meet stringent requirements and maintain the highest quality standards. Our QPs are experts in their respective fields and have a proven track record of success in guiding clients through the complex QP process.
Formulating Comprehensive Quality
Formulating comprehensive quality strategies that align with overall business goals and objectives, tailored to the specific needs of pharmaceutical and medical device companies. We work closely with our clients to identify their unique quality challenges and develop tailored solutions to address them, ensuring that both pharmaceutical and medical device products meet the highest quality standards.
GMP and GDP compliance
Ensuring regulatory compliance with all applicable regulations, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for pharmaceutical products, and ISO 13485 for medical devices. We stay up-to-date on the latest regulatory changes and provide expert guidance to ensure our clients maintain a robust compliance posture for both pharmaceutical and medical device products.
In addition to our core services, we also offer a range of value-added services, such as:
- Training and education to help staff stay up-to-date on the latest quality management practices for both pharmaceutical and medical device industries.
- Auditing and assessmentto identify areas for improvement and ensure QMS systems are functioning effectively for both pharmaceutical and medical device products.
- Regulatory consulting to provide expert advice on specific regulatory requirements for both pharmaceutical and medical device companies.
We are committed to providing our clients with the highest quality services and support, regardless of whether they operate in the pharmaceutical or medical device industry. Our team of experienced professionals is passionate about helping companies achieve their quality goals across both industries.
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