BATON Referral Network

Consultant with 30+ years of experience in biopharmaceutical facility design and validation; clinical and commercial manufacturing; quality systems; regulatory submissions and agency inspections.

Visionary problem-solver with a keen-eye on marketing, social media and operations strategy for medium, small, and start-up businesses. Experienced professional working with life sciences and healthcare companies for over 25 years.

With ISO 17025 accredited services, you will receive a calibration certificate, which exceeds GLP, GMP, ISO 9000 and CAP requirements. Whether you choose mail-in, on-site or pick-up, we will serve your equipment to the highest of standards.

Since 2009 we have been helping the scientific community identify and implement the most innovative and sustainable products for their facilities, through a pre-qualified portfolio of premier and specialized manufacturing companies.

Under the BATON program, Class Three offers early-phase medical device and diagnostic startups with an initial, high-level assessment of potential regulatory strategies and pathways their product at a discounted rate.

We offer an array of rheological tests on materials to quickly and quantitatively model real life applications. Outputs from these tests may provide better insight into product manufacturing, handling, performance, efficacy, and sensory attributes.

Our objective is to help organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective change management.
We are an energetic team of 70+ field-experienced professionals with skills in Engineering & IT Project Management, Commissioning, Qualification & Validation (CQV), Computer System Validation (CSV), Data Integrity, Quality, Compliance & Operational Excellence, Regulatory Affairs, and Training.

Twenty Five (25) years of diverse engineering, construction, CQV and capital project management expertise within the Pharmaceutical, Biotechnology, Industrial, Manufacturing and Chemical Process sectors.

Marketing & Branding Strategist helping businesses get more customers without ads, get them to come back and get them to buy more on each visit.
Additional: Product Marketing, Distribution Channels, Reputation & Visibility Marketing and Management

Business development, executive management, preclinical and clinical development, pharmaceuticals, neuroscience; Former President, NeuroGate.

A senior level executive with significant experience in medical and healthcare technology development including P&L, Operations, and M&A experience. An entrepreneur’s approach to biomedical innovation and management.

Er Ralston brings over thirty years of experience in numerous business improvement interventions. He is an accomplished coach, trainer, and advisor, specializing in operational excellence and planning to facilitate growth and profitability.

CPA with experience as CFO in multiple companies.

Life sciences; Business law; Securities law; Mergers, acquisitions & divestitures; Taxation; VC & private equity financings

The BlueWater Group, Inc. helps Organizations LAUNCH, GROW and SUCCEED by providing Manufacturing, Quality Management, Engineering, Supply Chain Management, Auditing and Training.

Patent preparation & prosecution; AgBiotech, diagnostics, biologics, biofuels, biomaterials, genome editing, protein expression systems & genetic engineering; legal opinions, due diligence, counseling & portfolio mgmt; corporate R&D experience

Square Hill is a healthcare consulting company that offers management consulting, commercial management and web and technology solutions.

As your business grows, so do your financial needs. Acuity understands this which is why we are known for our expert CFO services. You can rest knowing you have the support you need from the smartest financial leaders in the industry.

Retired Medtronic Executive. Globally capable medical device consultant with broad and deep expertise.

Companion diagnostics and biomarkers expertise: diligence, clinical utility, and financial. Managed six to seven-figure budgets to initiate and execute diagnostics projects. Experience with products that obtained FDA approvals and were launched.

Provides outsourced bookkeeping, controller and operational support for small to medium size companies, supporting HR Administration, Accounts Receivable, Accounts Payable, Fixed Assets, Month-end Financial Reporting and the Budgeting processes.

30 yrs industry experience in regulatory & quality mgmt positions, incl. start-up medical device companies. Directed/negotiated 510k clearances, IDE approvals, Modular PMA shell; Compliance; Facility inspections/ 483; Consent decrees; Quality systems

20+ years of scale-up & tech transfer experience for Biologics from pre-clinical to commercial manufacturing; Biologics manufacturing, tech transfer/process development, lab validation, regulatory communication; Ex-Apex Biosciences/, Diosynth, Eisai.

Experienced medical device professional with expertise in all aspects of product development and manufacturing.

Interim/part-time executive management and strategic consulting focused in therapeutic and personalized medicine test development and commercialization. Corporate product experience includes biologicals, pharmaceuticals and diagnostics.

We work with founders, CEOs, & senior management teams to structure & grow businesses from idea to commercial success: funding, government grants/contracts, strategy, commercialization & financial systems.

Biotech executive; particular expertise in rare and orphan diseases; other areas of considerable experience: drug delivery, pain, metabolism.

R&D collaborations, patent and technology licensing, university licensing, M&A; agricultural biotechnology, drugs and biologics, diagnostics, medical devices, genetic engineering, agronomic traits, animal health, precision ag, microbials

Experienced, professional consultant delivering a unique combination of technical and business information in all areas of life science: market research; business plan writing; strategic information & intelligence; SBIR grant preparation.

Regulatory, esp. Med Dev & Biologics (Cell therapies, viruses, vaccines); CDRH, CBER