GxP Consulting –
Quality & Compliance Solutions
Expert GxP guidance, ensuring quality and compliance excellence.
Swiss-Based, Globally Focused – We deliver exceptional services remotely and on-site worldwide.
Tailored GxP Services
Meeting Industry Standards
Are you navigating the complex quality and compliance landscape of the pharmaceutical industry? At GxPerts, we understand that each company has its unique challenges. That’s why our services are not just about meeting standards; they’re about creating solutions that fit your specific needs.
Imagine supplier qualification programs that do more than just fulfill the basic authority requirement, but helping to enhance your supply chain security. Think of internal audits and gap assessments that take your Quality Management System to the next level.
We focus on providing practical, tailor-made strategies to help you achieve and maintain compliance to the applicable quality standards and GXP excellence. It’s not just about passing an inspection; it’s about elevating and secure your entire operation.
How can we adapt our expertise to align with your goals?
Comprehensive GxP Compliance Portfolio
The goal is to provide clients with structured support across key areas of pharmaceutical development and operations. This includes regulatory and quality compliance, operational execution, and strategic planning—aligned with the specific requirements of each development stage and organizational context.
Quality
Assurance
Inspection and audit readiness are key for every GXP operation. A professional audit execution and a spotless inspection history are essential. Failing to comply with applicable regulations and properly managing quality incidences like deviations, out of specifications or audit observations can have severe business impacts. Our services offer customized inspection strategies to ensure preparedness, successful inspection execution, and compliant observation resolution.
- Inspection readiness assessments
- Mock inspections
- Inspection preparation plans
- Auditee and SME training
- Observation response and CAPA definition
- Non-compliance remediation programs
- Data integrity compliance assessments
- Quality Improvement Plans
Quality Management
Systems
A lean and efficient QMS is essential to achieve and maintain management and quality oversight. It prevents unwanted and resource-intensive deviations and audit observations while promoting continual improvements. We help you establish or transform your Quality Management Systems for enhanced efficiency and regulatory alignment through targeted improvements.
- Review of Quality Management Systems
- Process Improvement
- Data Integrity Assessments
- Process Training
Third-Party
Qualification
Secure your supply chain! Uncertain vendor quality and non-compliance with local SHE standards threaten pharmaceutical supply chains. Our risk-based vendor rating and qualification programs ensure that every vendor upholds strict compliance with applicable quality and SHE regulations.
- Remote and on-site vendor (supplier and service provider) audits
- Third-party qualifications, re-qualification audits, mock inspections, for-cause audits, etc.
- Quality, supply, and service agreements
- Quality questionnaires
Regulatory Affairs
& CMC
Strategic planning is essential when bringing a new drug to market. We support your regulatory and CMC activities from early development through commercialization—ensuring compliance, consistency, and readiness every step of the way.
Strategic Planning
& Execution
We support pharmaceutical companies in planning and implementing strategic initiatives—across organizational development, supply chain design or manufacturing scale-up. Our approach combines industry experience with structured methods to help you move forward with confidence.
Supporting Pharma Excellence: From Emerging Start-Ups to Industry Leaders
In the diverse world of pharmaceuticals, whether you are just beginning your journey as a start-up or managing the complexities of a well-established company, we understand your specific quality and compliance needs. We understand the unique challenges of your business model at each stage of your growth and offer practical, effective solutions.
Start-ups & Virtual Companies
For start-ups venturing into pharmaceuticals, navigating quality assurance and compliance can be daunting. Our approach involves working closely with you to prepare for regulatory inspections, ensuring your innovative ideas are compliant and market-ready.
Established Pharma Concerns
For established companies, maintaining and improving quality systems is crucial. Our services, such as QMS reviews, are designed to integrate with and enhance your existing processes, contributing to ongoing operational efficiency and compliance.
Global Supply Chain
Businesses
Managing a global supply chain comes with its compliance challenges. Our third-party qualification services provide thorough audits, ensuring each component of your supply chain meets required standards, enhancing overall quality and reliability and will provide you with the required GxP oversight and adequate level of control over all your outsourcing activities.
Martin Schneider
CEO & Founder of GxPerts
Dedicated to your success
in GxP for over 25 years
Hands-On
operational Excellence
Direct involvement in Quality Assurance, including FvP roles, with adeptness in managing Quality Systems, Control, Analytics, and ESH. Combining hands-on expertise with managerial excellence in Regulatory Affairs and CSV for comprehensive operational success.
Qualified Auditor for all
international GxP standards
Auditing experience in Europe, China, India Korea and Taiwan.
Strong Service
Mentality
Experience for CMOs and CDMOs in GXP environment, for Drug Products, Drug Substances and Cosmetics.
Compliance Remediation
Strategist
Developed the strategy for and lead the remediation activities after a statement of non-compliance or a warning letter
International Compliance
Success
Proven success in preparing and managing manufacturing sites for global authority inspections, including SwissMedic, FDA, EMA, EDQM, PMDA, MFDS, ANVISA and others.
Versatile Client Portfolio
With extensive GxP experience, we serve a diverse range of clients cross pharmaceuticals, biotechnology, and cosmetics industries, while maintaining strict confidentiality.
Send me a message!
Ready to elevate your compliance and operational excellence? Reach out today to discuss how we can achieve your GxP goals together!
Frequently Asked Questions about our GxP Consulting Services
What exactly is GxP in Regulatory Industries?
GxP stands for “Good Practices,” encompassing various quality guidelines and regulations in industries like pharmaceuticals and biotechnology. It ensures products are consistently produced and controlled to meet quality standards for their intended use.
What are the primary objectives of implementing GxP standards?
The main goals of GxP are to ensure product quality, safety, and efficacy in regulated industries, like pharmaceuticals, by standardizing and monitoring production and testing processes.
What industries does gxperts serve?
We primarily serve Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), traders, and manufacturing and analytical service providers for drug substances, excipients, and drug products.
How do we tailor your services to meet industry standards?
We conduct a thorough assessment of your company’s needs and regulatory requirements, then develop customized strategies and solutions to ensure compliance and enhance quality management processes.
What qualifications and experience do our consultants have?
Our consultants are highly experienced professionals with extensive backgrounds in the pharmaceutical and biotechnology industries. They hold relevant certifications and have a proven track record of successfully managing GxP compliance projects.
Can gxperts help with regulatory inspections and audits?
Yes, we provide support for regulatory inspections and audits, including preparation, management, and follow-up. Our team ensures that your processes and documentation are audit-ready and compliant with regulatory expectations.
Does the company offer training for the clients staff?
Absolutely. We provide comprehensive training programs tailored to your team’s specific needs, covering all aspects of GxP compliance and quality management.
How do you get started with our services?
You can start by contacting us through our website’s contact form or giving us a call. We will schedule an initial consultation to discuss your needs and how we can assist you. The first consultation is free and without obligation.
What sets gxperts apart from other GxP consultants?
Our personalized approach, extensive industry experience, and commitment to delivering high-quality, compliant solutions set us apart. We work closely with our clients to understand their unique challenges and provide tailored, effective solutions.
What is the typical duration of a GxP compliance project?
The duration of a project varies depending on its scope and complexity. During our initial consultation, we will provide an estimated timeline based on your specific needs and objectives.
Where are we able to provide our services?
We provide our services everywhere, either remotely or on-site at your location. Let’s talk and find the best arrangement for your needs.