Expert Consulting, Proven Results
Comprehensive GMP, regulatory, quality assurance and batch release services for pharma and biotech companies of all sizes.
What We Offer
Tailored solutions to help you achieve compliance, accelerate product registration, and ensure quality from concept to commercialization.
Consulting
Our team of experts are available to assist clients in navigating complex GxP compliance issues. We provide guidance to help you make informed decisions. Our consultants have years of experiences in dealing with complex regulatory and quality issues and can help you implement and maintain GxP compliant solutions.
Guidance and hands-on support to implement robust Good Manufacturing Practices that meet global standards.
Stay ahead of regulations with our guidance on Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). We help you navigate the complexities of compliance to protect your interest and those of your patients.
GxP Audits
We provide tailored GxP audit services that fit your requirements and audit program strategy. Our consultants ensure an audit provides you with valuable insights and actionable recommendations for compliance and improvement. We perform audits across GxP areas, conduct thorough evaluations of suppliers’ quality management system, critical manufacturing processes, quality control, contamination control strategy and outsourced activities.
- QMS Audit/Gap Assessment
- Supplier/Vendor Audits
- GDP and Supplier Chain Audits
- Inspection Readiness/ Mock Regulatory Inspections
- API, Drug Substance and Drug Product manufacturers
- GMP Laboratory Audit
Regulatory Compliance and CMC
With our expertise and experience in regulatory compliance we can support you in your regulatory process. Our consultants develop detailed regulatory strategies to suit your product, ensuring clarity and a clear path forward through all the significant milestones.
Providing strategic and technical review or authoring of regulatory submission, we ensure that the science helps drives your product through regulatory milestones.
Quality Assurance
Our experienced compliance consultants can support you in your quality assurance drive for better quality oversight and system functionality ensuring you have robust processes in place. We provide best practice recommendations to mitigate quality risks and those inherent to your business operations. We can work with your team to implement continuous improvement plans and collaborate with your team in addressing concerns. Our consultants have years of experience in quality incident resolution, system design, audit, implementation and improvement of quality management systems.
GxP Compliance
Our solutions consultants specializes in solving complex challenges. We can support you through various phase of your program ensuring that phase appropriate requirements are met and your business goals are achieved.
We can support you through establishment of GxP policies, framework and procedures. Our consultants have years of experience in commissioning, qualification and validation of computer systems, utilities, facilities and manufacturing processing.
We can support you through establishment of GxP policies, framework and procedures. Our consultants have years of experience in commissioning, qualification and validation of computer systems, utilities, facilities and manufacturing processing.
Qualified Person Service
We provide Qualified Persons (QP) service to bring your products to clinic or market. Highly experienced team assumes responsibility for all stages of the product lifecycle.
Our QPs work with your team to ensure compliance with global product registrations, execution of site audits, supple chain management and quality oversight. Our QPs have a broad experience in multiple dosage form manufacturing to support batch release.
Batch Certification
Companies that intend to manufacture or import medicinal products in the EU require a manufacturer/importer authorization (MIA) and a designated named Qualified Person to oversee the product quality throughout the supply chain. Attaining a MIA can be challenging and complex, CPS holds an EU MIA which allows us to help clients overcome the challenges of accessing the EU markets and relieves the need for MAH/Sponsors to obtain its own MIA license with a QP in the region. CPS can perform certification of MAH/Sponsors products under its MIA which helps ensure products are released for clinical or market supply
GxP Remediation Plan
Remediation of health authority observations can be challenging, our consultants are experienced in creating and managing remediation projects. We can support you in identifying corrective actions, responding to health authority and tracking every action item required per the remediation plan. We work with your team to perform necessary gap assessments, build your remediation plan and implement remediation actions to return your organization to a complaint state.