Numerous companies face challenges in maintaining the quality of their products and services, given the intricate landscape of legislation, standards, and certifications. We provide comprehensive Quality Assurance (QA) services essential for safely and compliantly bringing your product to market. This encompasses conducting in-depth cGxP audits conducted by certified auditors, the establishment of a Quality Management System (QMS), and all activities related to the final release of the product.
GMP AUDITING
With extensive global auditing expertise and up-to-date, in-depth knowledge of regulatory authority requirements worldwide, we furnish our clients with thorough, high-quality audit reports. Our focus is on ensuring compliance with all facets of EU and US Good Manufacturing Practice (GMP) guidelines, including Annex 16, specifically in auditing API, Drug Product, Packaging, and Laboratory Facilities.
QUALITY IMPLEMENTATION
SERVICES
A streamlined Quality Management System (QMS) should be in harmony with your business needs and objectives.
Our subject matter of experts possess the expertise, capabilities, and approach required to assist a company in developing and outlining a top-tier quality system. We provide ongoing QMS management support as required by our clients at their facilities.
We have reviewed and improved our client’s entire Quality Management Systems in line with cGxP principles. We have also developed complete lean and phase-appropriate Quality Management Systems for pre-clinical and start-up clients.
We offer simulated inspections for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). We provide coaching for individuals and teams involved in regulatory inspections, covering best practices for running the documentation room and managing the inspection process.
QP
SERVICES
Include services like Product Release, Permanent / Short Term QP Cover, Quality System Review & Implementation, Risk Management, Supplier Assessment Review & Management, API / Formulation QP Audits & Certification.
Our team of certified Qualified Persons (QPs) boasts extensive expertise encompassing various formulation types, intricate supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, Advanced Therapy Medicinal Products (ATMPs), and the supply chain for clinical trials.
RP & RPi
SERVICES
Our experienced RPs and RPI’s are qualified to the Cogent Gold Standard and we work to the latest GxP industry standards to maintain compliant quality systems. Our accomplished auditors have also completed and passed the CQI and IRCA certified (QMS) Lead Auditor Course.
QMS REMEDIATION
SERVICES
Our remediation services are designed to identify, address, and rectify compliance and quality-related problems within the Pharmaceutical, Biotech and Medtech industries.
Our experts adopt a risk-based strategy to enhance both quality and compliance, implementing proven practical solutions that yield results. This adaptable approach enables us to collaborate effectively with a diverse array of companies, including small startups, SMEs, and larger global organizations.
Throughout a remediation project, we actively collaborate on-site with the company to develop a new system, offering coaching and mentoring support throughout the project.
We provide a systematic approach to evaluate and improve quality control processes, helping manufacturers meet their quality objectives.
PHARMACOVIGILANCE
Our in-house team possess extensive expertise to assist pharmaceutical and biotech companies in the selection, implementation, integration, auditing, and optimization of pharmacovigilance systems.
Sustaining a pharmacovigilance (PV) system that aligns with regulatory standards and is tailored to your organization poses a formidable challenge. Drawing on years of practical experience and collaborating closely with all stakeholders, we assess your pharmacovigilance system, identify gaps, and design streamlined process frameworks that align with your organization’s requirements and regulatory standards.
We offer practical assistance in documenting various components and processes of the pharmacovigilance system, including Standard Operating Procedures (SOPs) and Work Instructions. Furthermore, we aid in maintaining a compliant Pharmacovigilance System Master File (PSMF) and provide guidance when considering the outsourcing of specific pharmacovigilance system components.
