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QUALITY AND REGULATORY SUPPORT

Simplifying the Complex to Achieve Business Goals

Looking to launch your product or respond to a global regulatory agency or notified body but not sure where to turn? Need help planning or executing your next project? Let us guide you.


JENLO Compliance takes an interdisciplinary approach to supporting our clients by leveraging extensive experience across multiple functional areas. We bring professionals with deep, broad, and diverse skill sets from areas within Quality, Regulatory Affairs, Manufacturing, Operations as well as former FDA inspectors to successfully complete projects by prioritizing those activities that will have the greatest impact on your organization.

 

REGULATORY COMPLIANCE SUPPORT

Proven Results from a Proven Team

Quality, regulatory, and commercial compliance ensure FDA regulated products are safe and effective and that the companies manufacturing and distributing them are operating in a compliant and ethical manner. In an era of additional and increasingly complex compliance requirements impacting industry, executives need a partner who works with them to achieve compliance while helping to deliver the organization's business goals. 

JENLO Compliance works with professionals to deliver that support across the following areas:

Revenue Neutral Compliance

Compliance has long been viewed as a cost center, but JENLO Compliance offers a unique approach to quality management by relentlessly focusing on its clients' business goals. We provide seasoned professionals to not only reduce company risk and ensure company compliance but look for opportunities to drive cost savings or open up additional revenue opportunities.

Services include:

  • Assessments

  • Audits

  • Regulatory Agency Responses

    • WL​

    • 483s

    • Seizures

    • Other

  • Remediation

    • Quality Systems​

  • Technical File Support

    • DHR, DMR, DMF

    • Data Integrity

  • Outsourced Quality Support

  • Inspection Readiness/Mock Audit 

    • Preparation and Training

  • EU MDR Support

  • Medical Device Single Audit Program (MDSAP)

  • ISO Certification Prep

    • 9001​ (QMS)

    • 13485 (Medical Devices-QMS)

    • 14971 (Risk Management)

    • 37001 (Anti-Bribery)​

Expert Guidance

JENLO Compliance stays on top of regulatory developments impacting the FDA regulated industry and uses that knowledge to advise companies on achieving their business goals by acting as the primary interface and advocates between the organization and regulatory authorities. 

We provide clear, defined, actionable regulatory strategies to reduce time to market, but also focus on providing the greatest flexibility to the commercial teams by negotiating the broadest indications possible.

  • Application Support for IND, DMF, NDA, ANDA, 505(b), BLAs

  • Requirements for investigational products (i.e. INDs and IDEs)

  • Orphan Products (Orphan Drugs, Humanitarian Devices (HDE), Minor Use Drugs)

  • PMA and 510(k) submissions including De Novo petitions

  • Preparation for and participation in Pre-Submissions Meetings and FDA Advisory Committee/Advisory Panel meetings

  • Label development strategy and review

  • EMA strategy and submissions support

  • eCTD publishing and submission support for FDA, EMA and Health Canada

  • Pre-Approval Inspection (PAI) Strategy and Support

  • Life Cycle Management and -post-approval change strategies (see also Field Corrective Actions)

  • Sales Training and MSL Training

  • GxP support activities

  • Risk Evaluation and Mitigation Strategies (REMS)

  • Post-Market reporting and adverse drug experience (PADE) (see also Complaint Handling/Adverse Event Reporting)

  • Change Control and regulatory submissions assessment

Simplifying the Complex

At JENLO Compliance we combine our insights and skills to transform your processes and strategies, and in turn, your company. We’re proud to help shape and improve how our clients structure and manage their business. A lot of law firms and consulting organizations within the life sciences space can tell you what you need to do and why in order to be in compliance. JENLO Compliance not only gives you the What and Why, but also provides you the How. 

While organizations look for opportunities to create growth and increase profits they are facing ever increasing regulatory requirements that increase pressure on their ability to deliver those results. JENLO addresses this head on by focusing on revenue neutral solutions in your process/system design and execution. 

Contact JENLO for help with the following:

  • Lean Enterprise

  • Green/Black Belt Training and Coaching

  • DMAIC

  • Designing Processes/Systems across the product life cycle (Business Systems, Operations, Quality Systems, Regulatory, R&D, Service)  ​​

  • Establishing Management Oversight

  • Leadership coaching

  • Making Requirements Operational, including:

    • FDA​

    • ISO

    • Malcolm Baldrige

    • Strategic Direction