About Advanced Biomedical Consulting (ABC), LLC

Cost-Effective FDA Compliance!

ABC provides a wide range of consulting services to industries associated with the manufacturing and distribution of Food and Drug Administration (FDA) regulated products. With a diversified workforce made up of published technical and regulatory experts in the pharmaceutical, medical device/diagnostic, biopharmaceutical, cosmetic, food/seafood, and animal feed industries, ABC can provide cost-effective solutions to nearly all issues encountered in FDA regulated industries.

The ABC Approach

From ABC?s process validation services to our representation of clients during regulatory agency inspections, ABC guarantees to provide ?hands-on? consulting services complying with the following ABC core business practices:

A. Provide cost-effective and sustainable solutions that are tailored to each client?s specific operations

B. Provide resources that are not only knowledgeable, but also willing and able to quickly implement the recommendations offered (i.e. ?Hands-On Consulting?)

C. Provide trained project management with each consulting project (regardless of size or scope of the project) to ensure timeliness and quality of all deliverables

ABC?s Goal...

To improve the technical and regulatory aspects of a client?s operations, so that both ABC?s business and the client?s business can enjoy growth together.

ABC's Services

? eCTD/CTD Conversions

? Vendor Audits

? Mock cGMP/Audits (Inspection Readiness)

? FDA Communications (e.g. Warning Letter/483 Responses)

? Process Validation

? Computer System Validation and Equipment Qualification

? State Licensing for Distributors and Manufacturers

? HACCP, FMEA, FTA (Risk) Procedures

? Label/Promotional Material Review

? Due Diligence Assessments

? MDR and AERS Compliance Assistance

? Design Control Implementation

? Expert Witness Services

? Contract Project Management

? Regulatory Agency Submissions

? DMF Generation

? Calibration and Maintenance Programs

? VAWD Certification Assistance

? Technical Drawing/Specification Generation

? Training

? New Facility Construction Consulting

? Technical Report Generation

? SOP Development

Contact Us

For more information contact us via a method most convenient for you.

P: (888) 671-4292

E: info@advancedbiomedicalconsulting.com

F: (888) 316-7537

Web: www.abcforfda.com