Balancing compliance with time to market in an agile environment
Fractional RA/QA/CA Consulting
Balancing risk to market with market traction
Successfully helped a start up neuromodulation company reclassify their device from a Class II to a Class III De Novo, substantially cutting time to market and submission cost
Estimated $3M in savings
Global Expedited Paths to Approval
Expertly obtained breakthrough device designation for a client developing a novel drug development platform, shortening their time to market and catalyzing an IPO. Experts in a multitude of expedited programs in the U.S. (HUD, BDD, FastTrack) & abroad
MedTech Strategy
Strategically helped a combination product company reorganize, paving the way for their empowering acquisition by a top-tier MedTech company
Bespoke Solutions: As unique as your technology & team
Seamlessly integrated IRB oversight and profit-restriction planning into humanitarian device commercialization strategies through the HUD/HDE FDA pathway
QMS solutions for today's agile product development
Expertly engineered and scaled Quality Management Systems (QMS) and electronic QMS (eQMS) from the ground up, modernizing legacy processes into integrated eQMS solutions that ensure continuous compliance and cross-functional alignment
Is your single site CLIA test ready for coming changes?
Proactively reclassified complex Laboratory Developed Test (LDT) portfolios into In-Vitro Diagnostic (IVD) compliant systems, expertly guiding labs through the shift from CLIA-centric processes to full 21 CFR 820 quality standards
WCLLC Proven Results
The WCLLC Way
Success for new technologies in highly regulated markets like HealthTech, MedTech and BioTech requires a balance between regulatory rigor and agile innovation. Compliance approaches and systems rooted in the past or mismatched to a company’s developmental stage can cause delays which can spell disaster for young companies. At WCLLC we get it: today’s innovators require a partner than gets this balancing act. Our solutions fall across three central pillars which drive us and the success of our partners: Compliance, Strategy and Market Access.
Our Services
How is your product regulated globally? What is the best pathway to speed time to market versus maximizing market impact?
Ranging from simple product classification(s) in varying global jurisdictions to bespoke, integrated global market access approaches, Welsford Consulting provides you with a regulatory strategy that matches the innovation of your technology. Clients typically use us for the following types of services:
USFDA access for devices and combination products (e.g., 510(k) versus De Novo versus PMA)
Global device classification and licensure requirements (LATAM, Canada, EU, EAA, EMEA, ASEAN, China)
CAP/CLIA (a.k.a. LDT) compliance and licensure
LDT to IVD conversions
SaMD submissions
AI/ML containing product submissions
QSubs and IDE submissions
STEDs and CE mark
BLAs and NDAs
Article 17 assessments and mitigations
Device (MAF) and Drug Master Files (DMF)
Biocompatibility strategies and mitigations for varying global jurisdictions
Quality Assurance - Mastering Compliance
Beyond waterfall: New products and processes demand flexible and adaptable systems which simultaneously support agile development while ensuring rigorous compliance. At WCLLC we have been using agile/sprint based design control methodologies for over a decade and are experts at implementing systems that match how you actually work so that building a culture of quality is seamless. Clients typically use us for the following types of services:
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QMS/eQMS authoring and stand up
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QSR to QMSR transition
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MDR/IVDR transition
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LDT (i.e., CAP/CLIA) to IVD(R) (13485:2016; QSR) transition
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PCCPs for AI/ML products
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MVPs and SDPs (IEC 62304)
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SW Requirements and Specifications for AI/ML containing products
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Integration of ISO 14971:2019 across the organization
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Production validation and manufacturing line stand up
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21 CFR Part 4 QMS integration and remediation
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DHF to MDF transitions
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Biological Safety Evaluation Plans and Reports (BSEP/BSER)
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CMC (device and drug/biologic) and aseptic processing
Clinical and Reimbursement - Accelerating Market Access
Does your clinical strategy support the product through to reimbursement? Have you picked the correct endpoints and is your trial design as forward looking as your product? At WCLLC we support your innovation past the clinic and into the market with Real World Evidence (RWE) and Bayesian/progressive designs which meet the evolving needs of your product. Clients typically use us for the following types of services:
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Clinical trial design (clinical protocols) for approvals and eventual insurance reimbursement
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RWE assessment and integration
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IDE, NDA strategy and submissions (e.g., eSTAR, eCTD)
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Statistical Analysis Planning and Study Powering
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Progressive (i.e., Bayesian) study designs
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Clinical Evaluation Reports (CER)
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Performance Evaluation Reports
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Post Market Clinical Follow Up Reports
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Clinical Trial Reports
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Analytical and clinical validation for LDTs/IVDs
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IRB/Ethics Committee Coordination and submissions
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Reimbursement support (e.g. CPT code application)