Gain FDA Compliance with Our Expertise

FDA Consulting for Drugs, Biologics, Medical Devices & Cosmetics

Close-up of water droplets on a dandelion seed head, with a blue background.

Physicians

-

Pharmacologists

-

Pathologists

-

Pharmacokineticists

-

Veterinarians

-

Toxicologists

-

Microbiologists

-

Statisticians

-

Chemists

-

Inspectors

-

Medical Device Experts

Physicians - Pharmacologists - Pathologists - Pharmacokineticists - Veterinarians - Toxicologists - Microbiologists - Statisticians - Chemists - Inspectors - Medical Device Experts

Our Dedicated Services

xFDA offers specialized services to support every stage of FDA compliance

Person in a suit reviewing a large stack of documents and paperwork at a cluttered desk.

Clinical - Guidance on trial design, safety, and efficacy evaluations.

Interior of a manufacturing plant with robotic machinery and conveyor belts for automation.

Quality Systems – Ensuring compliance with FDA quality and manufacturing standards.

Person wearing a blue shirt reviewing a document and taking notes with a pen at a desk.

Regulatory – Assisting with submissions, approvals, and regulatory strategy.

Three young professionals in business attire collaborating and smiling around a table in a modern office.

Training Solutions – Providing expert-led training on FDA requirements and best practices.

Person using a tablet and writing on documents with a pen on a wooden desk.

Compliance – Helping companies meet FDA regulations and prepare for audits.

A courtroom scene with a judge seated at the bench, surrounded by four women, one standing at her side. The judge is reading from a document, and the room features wood paneling and a scale of justice symbol above the bench.

Expert Witness – Offering experienced professionals for litigation and regulatory cases.

A man with a beard and headphones, wearing an orange shirt and apron, scanning boxes with a barcode scanner in a warehouse.

Serialization & Traceability – Ensuring DSCSA compliance and secure supply chains.

Medical monitor displaying vital signs, including heart rate, blood pressure, and oxygen levels, in a clinical setting.

Medical Devices – Supporting 510(k), PMA, and regulatory clearances.

Assorted skincare and cosmetic bottles on a marble surface amid green tropical plants.

Cosmetics – Assisting with FDA compliance, labeling, and safety requirements.

CONTRACT SERVICES/REVIEW AND ADVISE

xFDA consulting provides contract services for the approval of Drugs, Biologics and Clearance of Medical Devices by the Food and Drug Administration (FDA). xFDA consists of more than 150 consultants formerly FDA experts involved in the drug, biologic approval and medical device clearance processes. We offer a wide range of advice and services from preclinical trials, drug, biologic and medical device development, clinical trial protocols and support through the approval process and beyond. xFDA has investigators who can audit your facility and give you a gap analysis. xFDA can also assist with non-prescription drug products (over-the-counter).

OUR EXPERIENCE

xFDA consultants have extensive experience consulting on FDA affairs because they were experts at the FDA. They consult in the areas of human and veterinary medicine, toxicology, chemistry, pharmacokinetics, pharmacology, microbiology, statistics, and bioequivalence. xFDA has device consultants who specialize in FDA clearance of various types of medical devices. Many of our consultants have also worked in the pharmaceutical or medical device industry.

Our Consultants

Our experts offer tailored regulatory support to help you navigate FDA approval with confidence.

A man working at a desk looking at a computer monitor displaying a spreadsheet with data in colorful rows. There are glasses, notebooks, a pen, and decorative items like potted plants and a colorful rubber band ball on the desk.

Medical Officers

Providing strategic guidance on clinical requirements, safety assessments, and regulatory submissions.

Red blood cells flowing through a blue background, illustrating blood cells in a microscopic view.

Chemists

Ensuring compliance in drug formulation, stability testing, and Chemistry, Manufacturing, and Controls (CMC) processes.

Close-up of a scientist’s gloved hands adjusting a slide under a microscope in a laboratory setting.

Medical Device Experts

Assisting with medical device classification, FDA submissions, and quality assurance to meet regulatory standards.

Pharmacist in white coat holding prescription medication bottle and writing at a pharmacy counter with computer and glasses.

Serialization Experts

Helping manufacturers comply with regulations, ensuring seamless product traceability and authentication.

Close-up of a scientific microscope with adjustable lenses in a laboratory setting.

Medical Devices

Supporting approval pathways for Class I, II, and III devices, from development to post-market compliance.

COMPLIANCE AND INSPECTION

xFDA has FDA compliance consultants for mock inspections, audits and label reviews. xFDA offers FDA - GMP, GCP and GLP inspections.

DRUG DEVELOPMENT/SUBMISSIONS

Our FDA consultants listen to clients' needs and plan a drug development program specific for that firm's project. Our experts can draft regulatory submissions for firms or can review their regulatory submissions before submitting to the FDA.

GENERIC DRUG PRODUCTS

xFDA experts can advise firms with generic bioequivalence issues to help determine what studies will be required for the proposed drug product. We can advise on analytical methods, stability and other issues involved in the ANDA process.

LARGE AND SMALL CLIENTS

We serve a range of clients, from small startups to large pharmaceutical and medical device companies.    xFDA can also teach, guide and serve as an auditor and peer reviewer. xFDA is flexible and can supply parts of a team if a company is in need of only certain expertise.

GLOBAL REACH

xFDA supports clients worldwide in navigating FDA regulations for drugs, medical devices, and biologics. We assist with approvals, compliance, labeling, and investigators. Our former FDA investigators also audit U.S. and international manufacturing facilities for regulatory compliance.

Medical Device Regulations

  • 510(k)s
    Finding the right Predicate
    Classification of your medical device
    IDE
    PMA
    Read more...

FDA Registration and Listings

  • Manufacturers and Remanufactures
    Kit Assemblers
    Repackagers and Relabelers
    Contract Manufacturers and Contract Sterilizers
    Specification Developers
    Reprocessors of Single Use Devices
    Complaint Handlers
    Initial Importers
    Medical Devices
    Cosmetics

Serialization & Traceability

  • Strategic guidance and support services
    Our services include program management, regulatory compliance, standards compliance, implementation planning, serialization software vendor selection, trading partner management and integration, validation, troubleshooting, and training.

Healthcare Reimbursement

    • Healthcare Reimbursement

    • Healthcare Policy

    • Reimbursement Strategies

    • Reimbursement Payment

    • Coding/Coverage/Payment

    • Medicare Coverage

    • Category I &

    • Category III CPT Codes

    • Payer Relations

    • Payor Policy

    • Medical Devices

    Coding Guidelines for:

    • Medicare Billing

    • ICD-9 Coding

    • CPT

    • HCPCS Coding

    • C-Code

    • APC

Various pills and capsules spilled on a surface with digital medical icons and laboratory equipment in the background.

We Are Here to Serve You

Our team of experts provides specialized guidance across multiple disciplines to support your FDA approval journey.

Medical & Scientific Experts

Black caduceus symbol with two snakes intertwined around a staff and wings at the top.

Physicians

Providing clinical expertise to support regulatory submissions, safety evaluations, and FDA compliance.

Multiple glass Petri dishes filled with various pills and capsules, including white, pink, red, yellow, and orange, on a dark surface.

Pharmacologists

Assessing drug interactions, efficacy, and safety to meet FDA approval standards.

Scientist in a laboratory using a microscope, with another scientist working in the background.

Pathologists

Evaluating biological samples to ensure compliance with regulatory and clinical requirements.

A scientist wearing glasses and blue gloves examining a sample in a laboratory with a computer monitor displaying a microscopic image.

Pharmacokinetics

Analyzing drug absorption, distribution, metabolism, and excretion for regulatory approval.

Two veterinarians, a woman and a man, examining a gray tabby cat with a stethoscope in a veterinary clinic.

Veterinarians

Supporting animal drug approvals, safety assessments, and FDA compliance for veterinary products.

Female scientist in a laboratory conducting experiments with various scientific equipment and chemicals, with a window showing trees outside.

Toxicologists

Conducting safety assessments and risk evaluations to meet regulatory toxicity standards.

Regulatory & Compliance Specialists

A scientist in a lab coat reviewing a report with charts and graphs, seated at a lab bench with a microscope nearby.

Statisticians

Providing data analysis and statistical modeling for clinical trials and FDA submissions.

Male scientist or researcher in a white lab coat working at a laboratory bench with scientific equipment and chemicals.

Chemists

Ensuring compliance in drug formulation, stability testing, and Chemistry, Manufacturing, and Controls processes.

Two scientists in white lab coats and hairnets working in a laboratory, one holding a clipboard and the other wearing a face mask.

Investigators

Assisting with FDA audits, inspections, and reviews for regulatory compliance.

A person checking their blood pressure with a digital blood pressure monitor and a smartphone app displaying blood pressure readings, all showing normal blood pressure levels.

Medical Device Experts

Guiding medical device approvals, including 510(k), PMA, and regulatory compliance.

Two people shaking hands in front of the U.S. Capitol building.

US Agent

Foreign establishments choosing to do business in the U.S. FDA regulated industries must have an appointed U.S. agent before doing business and importing products into the United States

Need expert guidance?

Contact us today to accelerate your FDA approval process.