Navigate Pharma Regulations with Confidence: Technology-Powered Compliance.

In the complex Pharmaceutical landscape, robust compliance is paramount. GenBioCa goes beyond traditional consulting, offering technology-driven regulatory compliance services that streamline processes, minimize risks, and foster proactive adherence. Our core differentiator: deep integration of technology with regulatory expertise for efficient and future-proof compliance management. GxP Compliance (GLP, GCP, GMP, GDP), Compliance to regulatory standards – GDPR, 21 CFR P11, 4xx, 8xx, SOC2, FHIR, HIPAA, 510K, 13485 and many others industry frameworks covered, we offer Training, support in Addressing Warning letters. Support on Filing NDA/ANDA, Submissions, e-CTD.

The GenBioCa Advantage: Intelligent Compliance.

• Integrated Technology for Proactive Compliance: We seamlessly integrate cutting-edge digital tools to automate workflows, enhance data accuracy, and provide real-time insights for agile regulatory responses.
• Shifting from Reactive to Proactive Compliance: Anticipate challenges and build a sustainable compliance culture with our intelligent technology solutions and deep regulatory knowledge.
• Streamlining Compliance, Reducing Your Burden: Our expert consulting combined with technology optimizes processes, freeing your resources while ensuring continuous regulatory adherence.

Our Tech-Enabled Compliance Services:

• Multi-model Framework Compliance Management (Integrated Digital Platform – GenRAC): Centralized documentation, automated workflows, and real-time visibility for minimized errors and faster audits.
• Audit Readiness & Support (Real-Time Data Analytics): Data-driven insights and risk identification for confident and successful audits.
• Regulatory Intelligence & Change Management (Automated Alerts): Proactive monitoring and automated alerts to stay ahead of evolving regulations and ensure timely adaptation.

Benefits of Choosing GenBioCa:

• Reduced Risk of Non-Compliance
• Increased Efficiency and Reduced Costs
• Improved Transparency and Accountability
• Faster Time-to-Market
• Enhanced Audit Readiness
• Scalable and Adaptable Solutions

Client Success Story:

A large US-based consulting firm needed to harmonize regulatory needs and integrate a hybrid model with their quality systems. GenBioCa provided:

• Due diligence and gap analysis.
• A built hybrid model covering HIPAA, GDPR, 21CFR Part 11.
• Work templates, procedures, and SOP alignment.
• Integration with their quality systems.

Results: Delivered hybrid model and SOPs, trained teams, minimized breach/NC exposure, and ensured audit readiness through mock audits.

Ready for Intelligent Regulatory Compliance?

Visit www.genbioca.com or contact sales@genbioca.com to learn more.

For more information, please refer Regulatory Compliance Brochure

Q1: Why is regulatory compliance critical for Pharmaceutical and Life Sciences companies?
A: Regulatory compliance ensures adherence to global standards, avoids heavy penalties, minimizes risks, and maintains market standing and brand reputation.


Q2: How does GenBioCa help companies navigate the complex regulatory landscape?
A: GenBioCa offers a dedicated team and a suite of services, including regulatory automation, gap analysis, mock audits, and compliance management, to address evolving regulatory challenges.


Q3: What are the key drivers for prioritizing compliance according to GenBioCa?
A: Key drivers include close regulatory scrutiny, the need to optimize compliance costs, minimize risks, and maintain market reputation.

Q1: What is GenRAC, and how does it help with regulatory compliance?
A: GenRAC is GenBioCa’s Regulatory Automation Platform that helps organizations stay updated on global regulatory changes, refine submission strategies, and leverage AI for mitigation planning.


Q2: Which regulatory frameworks does GenRAC support?
A: GenRAC supports over 20 industry frameworks, including GDPR, 21 CFR Part 11, SOC2, FHIR, HIPAA, 5010K, and 13483.


Q3: How does GenBioCa ensure compliance with GxP standards?
A: We provide gap analysis, CAPA, mock audits, internal audits, and surveillance audits to ensure compliance with GxP standards.


Q4: Can GenBioCa help address regulatory warning letters?
A: Yes, we offer training, SOP management, and corrective actions to address and resolve regulatory warning letters.

Q1: What is included in GenBioCa’s gap analysis services?
A: Our gap analysis identifies compliance gaps, provides actionable recommendations, and helps implement corrective and preventive actions (CAPA).


Q2: How does GenBioCa prepare companies for regulatory audits?
A: We conduct mock audits, internal audits, and surveillance audits to ensure readiness for regulatory inspections.


Q3: What areas do GenBioCa’s internal audits cover?
A: We audit facilities, equipment, QC & QA functions, manufacturing processes, and maintenance activities (preventive and corrective).

Q1: How does GenBioCa assist with SOP management?
A: We help create, revise, and train teams on SOPs, ensuring alignment with regulatory standards and organizational needs.


Q2: What training programs does GenBioCa offer?
A: We provide training on GxP compliance, regulatory standards, software applications, and addressing warning letters.


Q3: How does GenBioCa ensure effective usage of software applications?
A: We conduct surveys, provide guidance, assess vendors, and offer training to ensure optimal usage of software applications.

Q1: What QMS services does GenBioCa provide?
A: We offer documentation, training, and implementation of QMS to ensure compliance with global regulatory standards.


Q2: How does GenBioCa support Good Laboratory Practices (GLP)?
A: We assist with laboratory documentation, waste management, and compliance with GLP standards.


Q3: What Good Manufacturing Practices (GMP) services does GenBioCa offer?
A: We provide documentation, change management, CAPA, trend monitoring, and quality improvement methodologies for GMP compliance.

Q1: Can GenBioCa assist with NDA/ANDA submissions?
A: Yes, we support the preparation and submission of NDAs, ANDAs, and e-CTD filings.


Q2: How does GenBioCa ensure successful regulatory submissions?
A: We refine submission strategies, conduct gap analysis, and ensure compliance with regulatory requirements.


Q3: Does GenBioCa provide support for post-submission activities?
A: Yes, we assist with responding to regulatory queries and ensuring post-submission compliance.

Q1: What laboratory support services does GenBioCa offer?
A: We provide resources, training, and safety and hygiene management for laboratories.


Q2: How does GenBioCa ensure laboratory compliance?
A: We conduct audits, implement waste management protocols, and ensure adherence to GLP and GMP standards.


Q3: Can GenBioCa help with laboratory documentation?
A: Yes, we assist with creating, revising, and maintaining laboratory documentation to meet regulatory standards.

Q1: What makes GenBioCa’s regulatory compliance services unique?
A: GenBioCa combines intelligent strategies, innovative technology (like GenRAC), and unmatched expertise to deliver tailored compliance solutions.


Q2: How does GenBioCa safeguard a company’s market position?
A: By ensuring compliance with global regulatory standards, we help companies avoid penalties, minimize risks, and maintain their reputation.