What we do

We help companies developing medical products define the regulatory pathway to market

Defining the Regulatory Pathway

We assess, define, plan, structure, analyze, and manage medical device, drug, and biologic development through the regulatory and clinical stages. We partner with our clients to create the most efficient pathway to success, sharing decades of experience that allows us to overcome barriers on the way to regulatory success.

Our Core Regulatory Services

Developing regulatory strategy

Facilitating discussions for due diligence and strategic partnerships

Developing regulatory opinion memos including US FDA and EU MDR classification

Managing submission projects

Coordinating and preparing for FDA meetings

Preparing pre-submission briefing documents

Developing clinical trial protocols, informed consent forms (ICF), case report forms (CRF)

Developing statistical analysis plans (SAP) and sample size calculations

Performing statistical data analysis and ongoing statistical support for clinical study reports (CSR)

Preparing & submitting:

Investigational Device Exemption (IDE) and Investigational New Drug (IND) Applications
510(k) Pre-Market Notifications
De Novo Petitions
Pre-Market Approvals (PMA) and New Drug Applications (NDA)
Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) Submissions
Breakthrough Designation Requests
Pre-submission Meeting Requests

Preparing for Advisory Committee review

Developing EU MDR strategy and submissions to obtain or support CE Mark

Our Specialized Services

Writing clinical study reports (CSR) and clinical evaluation reports (CER)

Preparing systematic literature review (SLR) protocols and reports

Preparing clinical evaluation plans (CEP) and General Safety and Performance Requirements (GSPR)

Writing state-of-the-art reports

Securing labeling approval and maintaining compliance

Writing peer review publications and manuscripts

Writing instructions for use and operators manuals

Medical device labeling, unique device identification (UDI) and labeling validation

Preparing abstracts

Preparing for FDA bioresearch monitoring inspections (BIMO)

Development and psychometric assessment of patient-reported outcome (PRO) measures

Establishing full quality assurance (QA) systems including standard operating procedures (SOPs) and medical device single-audit program (MDSAP)

Planning and overseeing testing including sterilization and biocompatibility

R&D engineering including creating manufacturing instructions and device traceability records

Assessing and reporting adverse events (AEs)

Conducting formative and summative usability evaluations for medical devices as part of the usability file and human factors report for FDA review

Assessing electrical safety, electromagnetic compatibility (EMC)

Conducting software verification and validation testing (software V&V)

Evaluating device software to ensure it meets cybersecurity requirements, including performing threat assessment, modeling, and testing

Regulatory Compliance and Post-Market Support Services

Designing and implementing complaint handling and customer feedback systems

Managing FDA Medical Device Reports (MDR) including electronic submission of MDRs to FDA

Managing vigilance systems for global adverse event reporting

Preparing post market surveillance (PMS) plans and reports

Preparing post market follow-up (PMCF) plans and reports

Drafting and reviewing promotional materials, claims, websites

Preparing for management review and PMS meetings

Assessing the need for and managing recalls and field corrections (reportable or voluntary)

Managing FDA Quality System Requirements (QSR) and ISO 13485

Supporting and preparing for FDA and ISO inspections

Conducting quality systems and supplier quality audits

Managing 483 observations

Managing warning letters