Services
Clinical Monitoring Services
Comprehensive clinical monitoring solutions tailored to the unique needs of each study. Our experienced clinical monitors and network of CRAs support every phase of the trial, ensuring quality, compliance, and operational efficiency across all therapeutic areas.
FDA 510(k) Consultation
Trusted 510(k) Consulting for Fast, Accurate FDA Submissions
Choosing the right 510(k) partner can be the difference between a smooth FDA review and months of costly delays. If you’re preparing a 510(k) submission and aren’t sure where to begin, or you’ve faced challenges with internal expertise, formatting, or past rejections. Mandic & Co. is here to support you.
Mandic & Co. works with medical device companies at any stage of the submission process, including teams navigating eSTAR for the first time. Our team ensures your submission is complete, compliant, and aligned with FDA expectations.
M&A Advisory
Why Mandic & Co?
Whether you’re buying or selling, Mandic & Co offers unmatched expertise in complex transactions across industries like healthcare, manufacturing, distribution, and retail. Our brokers combine technical rigor with relationship-driven insight—ensuring your objectives are understood, protected, and advanced.
We operate nationally and remotely, offering in-person consultations or on-site meetings tailored to your preferences. With Mandic & Co, you gain more than a broker, you gain a strategic partner!
Who we are
Mandic & Co is not just a service provider, we are a strategic ally committed to clarity, compliance, and commercial success. Whether advancing a clinical study, securing FDA clearance, or executing a high-stakes transaction, we deliver with precision and purpose.
Clinical Monitoring Services
Clinical Monitoring Services
Mandic & Co. provides comprehensive clinical monitoring solutions tailored to the unique needs of each study. Our experienced clinical monitors and network of CRAs support every phase of the trial, ensuring quality, compliance, and operational efficiency across all therapeutic areas.
A CRO‑Focused Monitoring Approach
We work closely with CROs to understand study requirements, timelines, and operational challenges. Our team adapts to the evolving needs of each protocol, offering flexible, scalable monitoring support that aligns with regulatory expectations and industry best practices.
Core Clinical Monitoring Services
Site Identification, Selection & Pre‑Study Activities
We help identify, evaluate, and qualify high‑performing sites to ensure readiness, compliance, and smooth study start‑up.
Initiation, Interim Monitoring & Close‑Out
Our remote and on‑site monitoring ensures continuous adherence to GCP, protocol requirements, and sponsor expectations throughout the study lifecycle.
Participant Safety & Rights Protection
We verify that participant rights, safety, and well‑being are protected at every stage, supporting ethical conduct and regulatory compliance.
Consent, Eligibility, Safety Oversight & Data Integrity
Our monitors ensure proper informed consent processes, accurate eligibility assessments, ongoing safety review, and high‑quality, reliable data.
Investigator & Site Staff Training
We provide comprehensive training to ensure site teams are fully prepared to conduct the study according to protocol and regulatory standards.
Informed Consent Translation & Verification
Our team manages translation, verification, and back‑translation of consent materials to ensure clarity, accuracy, and compliance across languages.
Regulatory & Ethics Board Submissions
We support the preparation and submission of documents to regulatory authorities and ethics committees, ensuring timely, accurate, and complete filings.
Protocol, Consent & Document Submission Management
We coordinate the timely submission of all required study documents to maintain compliance and keep your trial on schedule.
Investigational Product & Study Material Oversight
We oversee investigational product (IP), study materials, and drug storage to ensure proper handling, accountability, and regulatory adherence.
CRA Expertise
Our clinical research associates are highly trained professionals with deep experience across all phases of clinical research. Their expertise includes:
Protocol and data monitoring
eClinical systems (eCRFs, CTMS, EDC)
ICH‑GCP E6 R2, GDPR/HIPAA compliance
Oncology and other complex therapeutic areas
Issue identification, escalation, and resolution
CRAs provide ongoing guidance and support, ensuring each study is conducted to the highest scientific and regulatory standards.
Remote Monitoring
Remote monitoring offers a cost‑effective, efficient way to maintain oversight without frequent on‑site visits. Our remote services include:
Review of study documentation
Virtual site visits
Patient safety oversight
Data quality review
Continuous communication with sponsors and sites
This approach enhances efficiency while maintaining robust quality and compliance.
Risk‑Based Monitoring (RBM)
We apply a structured, risk‑based monitoring strategy to focus resources where they matter most. Our team performs detailed risk assessments for each protocol and designs targeted monitoring plans, including TSDV (targeted source data verification).
Benefits of RBM include:
Increased efficiency
Improved data accuracy
Enhanced patient safety
Stronger regulatory compliance
Multicentric Trial Support
With a global network of CRAs, we provide monitoring coverage across the United States and Europe. This allows sponsors to conduct multicenter trials with consistent oversight, regardless of geography.
We are committed to delivering high‑quality monitoring services across all regions, supported by experienced local and in‑house CRAs.
On‑Site Phase I Trial Monitoring
Our on‑site Phase I monitoring services offer:
Speed
Dedicated CRAs streamline communication and accelerate study progress.
Quality
Experienced monitors ensure Phase I trials are conducted with precision and adherence to protocol.
Cost‑Effectiveness
Our global CRA network allows for efficient resource allocation and reduced travel costs.
Flexibility
We tailor our Phase I monitoring approach to each sponsor’s needs, offering both local and in‑house CRA support.
Added Value
Local or in‑house CRAs available in the United States or European Union.
Flexible, sponsor‑aligned service model
Highly qualified staff using the latest technology
CRAs trained in ICH‑GCP E6 R2 and GDPR/HIPAA
Broad therapeutic experience, including oncology
Extensive Phase I experience in independent CPUs
Lead CRA coordination for multicenter studies
Consulting for Fast, Accurate FDA Submissions 510(k)
Trusted 510(k) Consulting for Fast, Accurate FDA Submissions
Choosing the right 510(k) partner can be the difference between a smooth FDA review and months of costly delays. If you’re preparing a 510(k) submission and aren’t sure where to begin, or you’ve faced challenges with internal expertise, formatting, or past rejections. Mandic & Co. is here to support you.
Mandic & Co. works with medical device companies at any stage of the submission process, including teams navigating eSTAR for the first time. Our team ensures your submission is complete, compliant, and aligned with FDA expectations.
Why 510(k) Consulting Matters
The 510(k) pathway is one of the most common routes to FDA clearance for Class II devices, but it’s also one of the most detail‑sensitive. Even minor errors can lead to Additional Information Requests (AIQs), extended review timelines, or an NSE (Not Substantially Equivalent) determination.
Mandic & Co. helps you avoid these setbacks by identifying issues early, such as missing documentation, unclear device classification, or formatting problems, so your submission moves forward efficiently.
eSTAR Submission Expertise
The FDA now requires all 510(k) and De Novo submissions to be completed through eSTAR, a structured electronic template designed to streamline reviews. While eSTAR improves efficiency, it also demands precise formatting and complete documentation.
Mandic & Co. helps your team:
Select the correct submission type (Traditional, Special, or Abbreviated 510(k))
Identify and justify the appropriate predicate device
Organize and format the eSTAR package correctly
Validate all required sections before submission
Avoid common errors that trigger AIQs or delays
Support Across Device Classes
Class I & Class II (510(k) Submissions)
Most Class I devices are exempt, but some still require clearance. For Class II devices, demonstrating substantial equivalence is essential. Mandic & Co. prepares strong, data‑driven submissions that include clear labeling, device descriptions, performance testing, and risk documentation.
Class III (PMA Submissions)
For high‑risk devices requiring PMA, eSTAR provides a structured way to present clinical data, manufacturing information, and post‑market plans. Mandic & Co. ensures your documentation is complete, accurate, and audit‑ready to minimize setbacks.Describe important details like price, value, length of service, and why it’s unique. Or use these sections to showcase different key values of your products or services.