BATON Referral Network

Business Area: Dietary Supplement, Food, Cosmetics, and Medical device
- Import & Export Support
- Business Development of New Ingredients(Natural/Botanical Ingredients)
- International Connection & Brokerage of new business
- Regulatory Support for Dietary Supplement & Food (US, Korea, etc)
- Coordination with non-clinical organization in Korea

Market and opportunity assessment, clinical and commercial planning, and strategy development for life science companies; Business development; Primary & secondary market research; Early stage valuation

Non-Executive Board Member. Medical Device and Clinical Trials CEO for multiple companies. Strengths are Strategy, Talent ID, Team Building and Growing businesses at accelerated rates.

I am a Healthcare Attorney that focuses my practice on representing healthcare providers and healthcare companies on regulatory, compliance and reimbursement matters.

Patent counseling, preparation and prosecution in life sciences and agricultural biotechnology including expertise in procuring plant patents and plant variety protection; patentability, validity, freedom to operate, infringement analyses.

My training is in organic chemistry and biochemistry. My research focuses on the design, synthesis and characterization of organic molecules, including peptides, for use as therapeutics and as tools to understand biological processes.

Transforming vision into reality for clients related to my experience building collaborations and bringing together the right people at the right time to make great things happen. Successful experience in consulting, investing alongside angel and VC firms, drug development, biotech, pharma, CRO management, R&D, project management, informatics, sales and marketing, strategy, leadership, working with and mentoring entrepreneurs and university spinouts, quality/regulatory, designing and building state of the art high tech facilities, building world-class academic programs, grant funding, exit strategy and acquisition planning, economic development, partnering with industry on workforce needs and talent pipelines. Experience representing state government on matters related to science, technology & innovation. Extensive board experience.

Expertise:
consulting
investing
drug development
CRO management
R&D and innovation
project management
sales
marketing
business development
leadership
strategy
working with entrepreneurs
mentoring
quality/regulatory
design and building high-tech facilities
creating world-class academic programs
grants
exit strategy/acquisition planning
economic development
partnerships/collaborations/alliances
academia
workforce training and talent pipeline
government experience
board experience

As a former FDA Investigator with 30-years of industry expertise, I prepare medical device and IVD companies to be ready for their next FDA inspection and Notified Body audit in the areas of compliance and quality.

- 30 years of experience in the creation, maintenance, remediation, and auditing of quality system and technical documentation for sterile and non-sterile medical device and in vitro diagnostics (IVD) companies from startup stage to fully commercial to ensure compliance with domestic and international quality and regulatory requirements.

- Support my clients by providing expertise in building, training, leading, and motivating high-functioning quality and regulatory compliance teams ensuring lasting knowledge transfer and inspection readiness.

- Talented internal and supplier auditor having practical experience with FDA inspection techniques, Quality System Regulation (QSR and QMSR), and on-site inspection procedures.

- Proficient in European and Global quality system standards such as ISO 13485, ISO 14971, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD) and associated Technical Documentation.

- Work extensively with contract design and manufacturing organizations (CDMO) to ensure that product is designed and manufactured in compliance with client, US, and international quality system requirements.

- FDA-483, Warning Letter, and Consent Decree responses and overall compliance.

Areas of Expertise:
FDA Regulations / QSR / QMSR
ISO 13485 Quality Management Systems
FDA Inspection Procedures
Quality System Inspection Technique (QSIT)
Quality Assurance
Quality Systems
Quality Control
Regulatory Compliance
Change Control
Culture Change
FDA Readiness and Remediation
Recall / Field Action
Complaint Handling
Internal, Supplier, Third Party Audits
Inspection and Testing
Process Control
Control of Nonconforming Product
Corrective Action (CA)
Preventive Action (PA)
Qualification and Validation
Design Control
Management Review
Project Management
Clinical Trials
Sterilization
Product Stability
Calibration
Preventative Maintenance
ISO 14971 Risk Management
ISO 9001 Quality Management Systems
ISO 19011 Audit Management
AIMD / MD / IVD / Biotechnology
Start-up companies
Class I, II, III Medical Devices
Expert Witness

If you’re a visionary leader at a growth stage biopharma company, I help you identify a calculated and informed path to scale — one that mitigates risk, maximizes value, and capitalizes on your existing successes.

My frameworks provide a proven path to sustainable growth and enhanced enterprise value by overcoming common challenges, such as:

-Revenue plateaus
-Operational disruption
-Risk exposure

This stops leaders of biopharma companies from achieving:

-Sustainable growth
-Operational scalability
-Proper risk identification and management

📈 HOW I GET RESULTS FOR MY CLIENTS

As a trusted Business Advisor with decades of experience in the life sciences sector, I help small to midsize Biopharma companies achieve sustainable growth, accelerate time to market, and mitigate risks - allowing industry leaders to put their stamp on their company’s future!

→ Maximize the value of your acquisition or strategic alliance, expedite functional due diligence and time to close, and integrate seamlessly.

→ Accelerate time to market and maximize your enterprise value.

→ Mitigate risk and limit exposure that is inevitable in the growth lifecycle of your company.

✅ WHO I WORK WITH

Founders and Executives of growth stage Biopharma companies who are:

-Balancing aggressive growth targets and practicalities of limited resources
-Looking to maximize the value of a strategic acquisition or industry alliance
-Concerned about potential operational risks through the growth lifecycle
-Working to improve enterprise value to attract further investment

In the dynamic landscape of today's business world, Purple Raven stands as a stalwart partner, dedicated to
ensuring the heartbeat of your business never falters. We recognize the relentless nature of cyber threats,
regulatory pressures, and customer demands, and we are here to fortify your organization against these
challenges. Our commitment is not just to security but to the seamless integration of robust cybersecurity
measures into your business strategy.

1. Provide three distinct professional services: Enable – Establish a culture of excellence to build in quality and avoid the costs of poor quality; Solve – Provide problem solving expertise and applying over 30 years of practical experiences to solve the organizations most critical issues; and Enable – Equip an organization’s employees through training and development.
2. Fractional or Permanent leadership role in Quality, Continuous Improvement, or Transformation leadership.

Competencies:
LEAN, Six SIgma, Continuous Improvement, Process Design, Product Development, Risk-based Quality Management, Customer Quality, QA, QC, Regulated Industries, Global Standards, Medical Devices, GMP, Life Sciences, Operations, Manufacturing, Product Services,

Quality Assurance and Compliance; GCP/GLP/GCLP/GMP/CSV/Part 11; Training, auditing, SOPs; drugs, devices, biologics, dietary supplements

Enthusiastic and motivated biologist focused on the biomedical field. Professional experience developed in clinical laboratories, academia, as well as the corporate and consulting worlds. More than 50 papers published in the biomedical literature and over 140 presentations delivered in scientific meetings. Serves as a reviewer for medical journals. Excellent instructor and respected speaker. Member of various professional organizations and active participant in scientific committees. Utmost professional integrity and work ethics, team-oriented, hard-working, and efficient person committed to meeting deadlines. Works collaboratively and efficiently across multiple disciplines and groups.
Languages: English, Spanish, and Catalan

Chris is the Principal Consultant at Xyzagen. Xyzagen is a drug discovery and clinical pharmacology consulting and services firm. Xyzagen, provides consulting, PK modeling, and nonGLP rodent pharmacology, bioanalysis and PK in their laboratory space.

Global experience in drug and device clinical development/safety monitoring, business development, regulatory interactions and public-private partnerships;board-certified neurologist/epileptologist;patient advocate; clinical and industry consultant.

Cintas Cleanrooms use a highly specialized laundering process with strict standard operating procedures and stringent requirements that meet and maintain ISO 9001 certification. We provide gowning services and cleanroom supplies to ensure that your facility is functioning at peak performance.

A full-service international consulting and product management firm that provides CMC development, manufacturing, regulatory affairs, launch, and operational support to pharmaceutical and biotech companies.​

Providing supply chain and clinical distribution support to early-stage and venture-funded biotechnology and pharmaceutical companies:
- Drug product fill/finish.
- Drug product packaging and labeling.
- Drug product and ancillary inventory management.
- Clinical supply distribution.
- IRT management.

Experienced drug discovery professional, medicinal/organic chemistry, pharmaceutical/agricultural/personal care chemistry, discovery CRO management, lab operations, IP expert, technology transfer assessment & due diligence, site start-up

I work with businesses and nonprofits to help tell their stories via digital media in various industries including healthcare, biotechnology/biopharma, and animal welfare.

I have directed communications programs for stakeholder engagement through public affairs, social media / content marketing and advertising. I'm also a content creator with 20+ years experience growing company's digital footprints and optimizing strategies across platforms. I leverage my expertise in storytelling, paid digital media, and social media analytics to gain insights and help grow brand presence.

My current areas of focus include: social media, storytelling and public relations

Experienced Board Member, CEO and senior executive with proven ability to build, develop and grow international businesses. A highly strategic and results focused visionary leader for building and developing early stage, turn-around, and established companies. Repeated success in leading early stage and established companies to the next level of growth and expansion. Extensive and diverse experience that provides valuable perspectives and insights to Boards and corporate management across the company in setting vision, focus, goals, and strategies that produce the best possible results. Balancing drive and passion for growth with fiscal responsibility while generating the highest possible ROI.

Edgerton Data Consulting assists pharmaceutical, biotech, and medical device company sponsors with CRO selection and clinical trials oversight to ensure data management, biostatistics, and CDISC deliverables are timely, complete, and accurate.

Contract Research (CRO), Biostatistics and Statistical Programming, External Committee Organization and Management, Clinical Development, Data Management, Medical Writing, and Project Management

PhD patent attorney with over 22 years of in-house and private practice experience across a range of technologies, including diagnostics, pharmaceuticals, vaccines, recombinant DNA and proteins, and medical devices. Past clients include Johns Hopkins, every ACC school in NC, Wyeth, Syngenta, Illumina, Catalent, and various start-ups and independent inventors.

Optimized communication for individuals and teams including executive leadership for improved outcomes in workflow and bottom line. Talent Integration, Pitch Team Coaching, , Strategic Alignment of Team within Organization, Leadership Development, Communication Intelligence, Creative Mindset, Reorganization, Onboarding, Board Engagement, Talent Retention, Equitable Meetings, Assessment.

NC Fisher Research provides thoughtful SBIR and STTR grant preparation strategy and consultation. The technical expertise is biomedical, focusing primarily on grant submissions to the National Institutes of Health.

Patent preparation, prosecution & enforcement; Patent searches; Patentability, infringement and validity opinions; Due diligence; Trademarks and copyrights.

Aisha counsels biotechnology companies regarding competitive and quality intellectual property portfolio building and strategy.

Our customers work with us because they require expertise in life-sciences focused cloud engineering and cloud platform governance and operations, but also networking and data security expertise to help them advance their initiatives successfully, on-time and on-budget. Our larger competitors are unable to move as fast, and our smaller competitors lack our expertise.

We provide cloud and managed services to allow our customers to reap the benefits of cloud while improving performance and minimizing the risks. Our customers are innovative life sciences companies that require the speed and power of the cloud to achieve their business objectives.

We help life science innovators accelerate the identification of viable target molecules. We do this by learning which scientific and analytics tools will be used. From there, based on the tools, we build and manage an on-demand compute platform with AI/ML capabilities from AWS. Our flexibility and availability make it easy. The platform is on-demand, so we do our best to match that functionality.