About ABC

Advanced Biomedical Consulting, LLC is a member of the ABC family of companies, a group of companies known for providing both cost-effective and extremely high quality products and services. 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. Click here to see a list of current and recent ABC projects.

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 Cost Savings Programs

In addition to our cost-effective rates that are often times less than half that of our competitors, ABC also offers several programs to both our current clients and prospective clients in order to stretch the consulting services budget. Click on a link below for a brief description of each of our Cost Savings Programs.

• Cash Back Program
  
  
  Have a long-term project or multiple projects planned for the year? Then, take advantage of ABC’s Cash Back Program. When your company reaches predetermined levels of services with ABC, we will provide a rebate of up to 10% of the labor costs at the end of the year!
  
  
• Referral Program
  
  
  Know someone in another department or another company who may be interested in one or more of our services? Let us know, and we will credit you with free days of consulting.
  
  
• Frequent Flyer Program
  
  
  Are you a small business or only have a need for a few projects requiring our services here in a calendar year? Then, check out our Frequent Flyer Program. Hire us back for another project within a specific amount of time, and you and your company can get a discount on that next project up front!
  
  
• Test Drive Program
  
  
  Not sure if we are the ones to go with? Take us for a test drive! Provide ABC the opportunity to tell you and select other decision makers in your company what we do, and we’ll give you a day of free consulting services. That’s free document review, vendor assessments, validation, procedure writing, etc., just for the opportunity to introduce ourselves to your organization.

For additional details about our company, services, or Cost Savings Programs, contact us and someone will get back to you immediately with answers to your questions.

• Warehouse Mapping - Dietary Supplement Manufacturer
• Decontamination Process Development – Medical Device Manufacturer
• Facility Acquisition/Due Diligence Assessment, - Injectable Pharmaceutical Manufacturer
• HPLC Performance Qualification (PQ) - Contract Pharmaceutical Testing Laboratory
• e-Pedigree System Implementation – Ophthalmic Pharmaceutical Manufacturer
• Sitewide Quality Program Implementation - Topical Pharmaceutical and Cosmetics Manufacturer
• 510(k) Submission – Orthopedic Medical Device Manufacturer
• Process Validation - Generic Solid Oral Dose Pharmaceutical Manufacturer
• Drug Master File (DMF) Submission - Medical Component Manufacturer
• Registration Compliance Assessment – Dental Medical Device Manufacturer
• Manufacturing Facility Compliance Assessment, - Homeopathic Drug Manufacturer
• Injection Molder Installation and Operation Qualification (IOQ) – Ophthalmic Medical Device Manufacturer
• Incoming Component Inspection Program Development – Diagnostic Product Manufacturer
• Validation Program Assessment – Novel Immunotherapeutic Product Manufacturer
• FDA Warning Letter Response Generation – Sunscreen Manufacturer
• Raw Material Compliance Assessment - Novel Pharmaceutical Dosage Form Manufacturer
• FDA Audit Client Representation - Diagnostic Equipment Manufacturer
• Facility cGMP Compliance Assessment – Topical Pharmaceutical Manufacturer
• FDA 483 Response Generation – Medical Cable Manufacturer
• Expert Witness Services – Leading International Law Firm
• Verification Audit/Assessment - Veterinary Otic Solution Contract Manufacturer
• HVAC System Installation and Operation Qualification (IOQ) – Pharmaceutical R&D Facility
• Tablet Coater Performance Qualification (PQ) – Private Label Pharmaceutical Manufacturer
• Validation Program Development - Plasma Fractionation and Blood Banking Organization
• cGMP Training – Vaccine Manufacturer
• Calibration and Maintenance Program Development and Implementation – Biopharmaceutical Manufacturer
• HAACP Program Development– Seafood Processor and Food Manufacturer
• USP Water System Compliance Assessment/CAPA Implementation – Liquid Oral Dose Pharmaceutical Manufacturer
• Vendor Audit – Pet Product Manufacturer
• Microbial Contamination Investigation Plan & Report Generation – Medical Food Manufacturer
• Cleaning Validation - Generic Solid Oral Dose Pharmaceutical Manufacturer
• Product Label, Website, and Marketing Material Compliance Assessment – Cosmetic Product Manufacturer
• Sterilization Validation – Single Use Device (SUD) Reprocessor
• Validation Master Plan Generation – Novel Biotechnology Product Manufacturer (Clinical Stage)
• FMEA Manufacturing Process Risk Assessment - Biopharmaceutical Manufacturer
• Standard Operating Procedure (SOP) Development – Orthopedic Device Manufacturer
• Electronic Common Technical Document (eCTD) Software Validation - Ophthalmic Pharmaceutical Manufacturer