Welcome
MET Servicing, LLC Regulatory Affairs Consultancy
Specializing in FDA Medical Device, Pharmaceutical development and Submissions
Who We are
Who We Are
Michael Tomasovich, MS RAC is President and CEO of MET Servicing. Michael has worked in regulatory affairs for over 20 years with companies both large and small including firms such as Abbott, BD, Medtronic and Smile Direct Club.
Michael holds a Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University and a Bachelor of Science in Paralegal Studies from Eastern Michigan University where he graduated Magna Cum Laude. Michael also has an Associate Degree in General Studies from Montcalm Community College where he graduated with high honors.
Michael is Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society (RAPS).
MET Servicing also engages the services of other consultants based upon the needs of the client. These consultants have 20-30 years regulatory experience and have held positions as FDA reviewer, VP of Regulatory and Quality, and Director of Regulatory Affairs. These consultants are brought to the project as plug and play modules based upon their expertise and need. As the need dissipates the consultants leave the project keeping the work streamlined and overall project cost down.
Medical Device Services
Regulatory Assessment
Our team will prepare a regulatory opinion paper (whitepaper) addressing development and commercialization of the product. The assessment includes:
- The best regulatory route to market
- The appropriate governing regulation and product code
- Identification of potential predicate devices
- If a regulatory filing with FDA is needed, and if so, is it a 510(k) or PMA
- A notice of whether a meeting with FDA is needed
- Proposed testing and support documentation needed
- Timing and costs involved
Pre-Submission/Q-Sub/Pre-IDE Meetings
Meetings with FDA are critical events. They introduce the medical device and company to FDA and establishes what FDA wants to see in a marketing application. MET Servicing uses senior level regulatory experts to prepare the meeting request in accepted FDA format (PreStar). The specialist prepares the supporting briefing package (device information, diagrams, materials, specifications, etc), identifies the proposed predicate(s) showing the comparison between the device(s), and develops the appropriate relevant questions for FDA to consider. Following the successful meeting the sponsor knows and understands what needs to be done to get its device to market.
Marketing Submissions
MET Servicing helps clients bring new medical devices to market in a timely, efficient and cost saving manner. The submissions related to medical device clearance/approval include:
- 510(k)/eSTAR - Traditional; Special; De Novo
- PMA and PMA supplements
- IDEs
- In Vitro Diagnostics (IVD and IVDR) and Companion Diagnostics
- Software as a Medical Device (SaMD)
- Emergency Use Authorization (EUA)
- Drug/Device combination products
QMS
At MET Servicing we believe a successful product starts with a strong quality system. Quality must be built into the device and creating, updating or revising a Quality Management System to meet the requirements of 21 CFR 820 and/or ISO 13485, MET Servicing can assist with that goal. The MET Servicing team is ready to assist clients be prepared for the implementation of the Quality Management System Regulation (QMSR) for FDA which takes effect February 2, 2026. Don't wait to see if your current system meets the requirements.
Labeling
Labeling incorporates not only what is on the product but marketing material and websites as well. MET Servicing is especially adept at helping clients create the appropriate labeling while complying with FDA requirements including UDI (Unique Device Identification) and GUDID registration. MET Servicing can lead the way in creating UDI compliant coding, establishing and recording UDI information in the GUDID database, and making sure that all other labeling is compliant with FDA clearance.
Registrations
Navigating the FDA website can be confusing. Let MET Servicing do the work for you. MET Servicing experts can easily register and list a company and its device(S). MET Servicing also can request a GUDID account and create the appropriate UDI listing.
Regulatory Agent
Foreign sponsors must have a US Regulatory Agent for submitting to FDA and for acting on behalf of the foreign company. MET Servicing can serve this role as it has done for many customers.
Pharmaceutical Regulatory Services
Regulatory Assessment
Our team will prepare a regulatory opinion paper (whitepaper) addressing development and commercialization of the product. The assessment includes:
- The best regulatory route to market 505(b)(1), 505(b)(2), ANDA, or OTC
- The appropriate preclinical testing
- Analytical methods and validation
- CMC
- PIND meeting requirements and timing
- Clinical Precis / Protocol development
- Timing and costs involved
PIND, Type A-D, & Pre-OMOR Meetings
Meetings with FDA are critical events. They introduce the product and company to FDA and establishes what FDA wants to see in a marketing application. MET Servicing uses senior level regulatory experts to prepare the meeting request in accepted FDA format. The specialist prepares the supporting briefing package (Toxicology, Preclinical, CMC, Protocol, literature support, etc), and develops the appropriate relevant questions for FDA to consider. Following the successful meeting the sponsor knows and understands what needs to be done to get the IND approved and begin first in man studies.
Marketing Submissions
MET Servicing helps clients bring new drug products to market in a timely, efficient and cost saving manner. The submissions related to a new drug product include:
- IND, NDA, ANDA
- Additional Sequences
- Annual Reports
- Withdrawal / Inactivation
Met Servicing follows all eCTD formatting requirements and utilizes Docubridge One submission software for creating the Application/Sequence. All submissions are validated prior to upload into FDA's Next Gen ESG.
Labeling
Labeling incorporates not only what is on the product but marketing / study material and websites. MET Servicing is especially adept at helping clients create the appropriate labeling while complying with FDA requirements. MET Servicing can assist with drafting the Investigator's Brochure, patient or physician documents as well as all other required labeling (Ad/Promo, OPDP Form 2253, etc.) .
Regulatory Agent
Foreign sponsors must have a US Regulatory Agent for submitting to FDA and for acting on behalf of the foreign company. MET Servicing can serve this role as it has done for many customers.
Cosmetics and Dietary Supplements
Regulatory Assessment
Our team will prepare a regulatory opinion paper (whitepaper) addressing development and commercialization of the product. The assessment includes:
- The best regulatory route to market
- Ingredient / Claims review
- Labeling review
- Registration requirements
Registration
FDA recently changed from voluntary registration to mandatory registration for cosmetic products and facilities. Let MET Servicing navigate the registration requirements ensuring full compliance with FDA reporting requirements.
Labeling
Labeling incorporates not only what is on the product but marketing material and websites. MET Servicing is especially adept at helping clients create the appropriate labeling while complying with FDA requirements. MET Servicing can assist with drafting the appropriate product statements for premium product marketing.