GxP-CC | Life Science Regulatory Compliance Consulting

We help pharmaceutical and health sciences companies comply with complex and evolving regulations and quality standards. Small and nimble, we’ve designed GxP-CC for maximum flexibility, so we can provide the highly customized and collaborative compliance solutions Life Sciences clients need to move projects forward with confidence. No matter your target market, GxP-CC makes streamlined compliance your competitive edge.

Our Services

Instill best practices that ensure sound data is at the core of every phase of product development.

Digital Compliance & Protection

Mitigate risk with solutions that meet regulatory requirements within the framework of your unique operational needs.

Quality Compliance

Translate regulatory requirements into the technical and procedural tools that turn a quality strategy into reality.

Computer System Validation

Pair process expertise to your specific validation needs for a tailored solution to best practices.

Meet Our Experts

GxP-CC’s team of scientists, pharmacists, engineers and IT professionals bring a powerful blend of academic rigor and practical field experience to every engagement.

Vinicius Tarantino

IT Compliance & Security Manager

Partner, VP of International Operations

Dr. Ulrich Köllisch

Associate Partner

Jyotee Rudramurthy

Arpita Sundaria

Dr. Thaleia Papadopoulou

Dr. Katherine LaClair

Compliance Consultant for Data Integrity in Life Science

Life Sciences

View All Life Sciences

Research & Development

Modernize your operations with digital solutions that deliver transformative insight and lean efficiency.

Discover how a streamlined pathway toward compliance can drive faster, leaner, and more cost-effective manufacturing decisions.

Commercialization

Unleash the full power of data-driven insight to better classify, monitor, and store data and improve pharmacovigilance.

Put systems in place that strengthen connections with external partners and deliver deeper insight into distributed product logistics.

We Deliver Results

We’ve earned our reputation for driving the results that help Life Sciences companies make a bigger impact worldwide.

82%

Reduced speed to market

81%

Increase in speed to hire and train staff

2.5x

More likely to be on budget and on time

500+

Projects in twenty eight countries

Our Latest Thinking

The Benefits and Challenges of Digitalization in the Lab -Lab 4.0-

AI/ML in Drug Manufacturing: FDA’s discussion paper and PDA’s comments

Shielding Critical Life Sciences Data from Cyber Threats

Navigating AI Implementation in GxP Environment

Unleashing the Power of Technology in Clinical Trials: FDA’s Latest Guidance on Electronic Systems, Records and Signatures

Artificial Intelligence in GxP Regulated Environments: How to Harness its Power While Mitigating Risks

Summary of APIC’s FAQ document on Data Integrity

Highlights des Konzeptpapiers zur Annex 11 Revision

How ISO 27001 certification ensures data integrity

Common Data Integrity Points of Failure: 3rd Party Management

Data Integrity in Pharmaceutical Manufacturing, March 23, 2023 – Recording available

Highlights of the Concept Paper on the revision of Annex 11

Join Our Team

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