About Us...

Excellent Pharma Consulting is comprised of a network of industry experts who are available to offer quality, regulatory, scientific, technical and practical guidance with a variety of regulatory, quality, manufacturing, software, and compliance issues. Our experts all have practical experience in the pharmaceutical (active pharmaceutical ingredients through finished products), biotechnology, cosmetics, food, or device industries.

Contact Us At +1 847 837 8191

Microbiology / Sterilization

Our expertise can assist with all aspects of microbiology in manufacturing or laboratory operations including implementing rapid micro methods, establishing an environmental monitoring program, sterilization cycle development and assisting in microbiological contamination investigations.

Regulatory

We offer a wide range of Regulatory Affairs and Regulatory/Quality Compliance expertise including:

  • Development of regulatory submissions.
  • Managing regulinspections.
  • Performing electronic submissions.
  • Facility and Product Listing registrations.
  • Acting U.S. Agent.

Quality Management

Quality management ensures that an organization, product or service is consistent. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it.

Gomming Soon........

Spend an hour with with us and some of your peers discussing current issues and trends in microbiology, sterilization, changes in regulations and changes in technlogies.

We will be hosting periodic ‘lunch and learn’ webinars to discuss current topics and have open discussions with members of the industry.

Please check back for the for registration instruction and schedule.

Regulatory

Expertise in regulatory requirements such as:

  • FDA Submission developement and review.
  • Compatibility protocols.
  • Development of CMC sections of submissions.
  • Registered Agent.
  • Audit Preparation and Audit Responses.

Quality Management

We can provide guidance in:

  • Develop risk based Quality Management System
  • Compliance evaluation and support.
  • Establishing GxP systems and procedures.
  • Prepare or manage regulatory inspections.
  • System or procedure assessmennts.

GMP Compliance

We can help you address all your compliance requirements.

  •  Process and equipment validations.
  • Documentation management
  • Change Control management
  • Training programs
  • Corrective and Preventative Action program.
  • Application of Risk Analysis
  • Design History and Device History requirements
  • Production and Process Controls

Microbiology

Let or group of experts help you with:

  • Rapid micro process development and implementation
  •  Laboratory Management
  • Sterility Testing
  • Environmental Monitoring
  • Microbial Data Deviations (MDDs) and Out-of-Specification Analysis
  • Cleaning and Cleaning Validation Support
  • Media Fills / Process Simulations

.Jeanne Moldenhauer, Vice President, leads our consulting division. All of our senior level consultants all have a minimum of ten years practical experience in their respective areas of expertise. Included in this expertise is a proven history of successful projects, a strong base of experience dealing with domestic and international regulators.  

  • Regulatory Support 26% 26%
  • Process Design 8% 8%
  • Quality Manage,emt System 31% 31%
  • Validation 8% 8%
  • Environmental Monitoring 16% 16%
  • Microbiology / Sterilization 11% 11%

Meet the team….

Associate 1

Associate 1

A microbiologist with over 25 years of experience which includes sterilization  cycle development, bioburden testing, closure/container/ packaging integrity testing, biological indicator development and evaluation, environmental monitoring.

Associate 2

Associate 2

Associate 2 has extensive experience in FDA inspections and regulatory compliance having had responsibility for external and internal audit programs in QA management.

Associate 3

Associate 3

An established quality control biopharmaceutical/pharmaceutical microbiologist with extensive global good manufacturing practice (GMP) experience including laboratory design, training and developement, new technologies, risk assessments, process and equipment validation and microbial identifications.

Associate 4

Associate 4

An accomplished and experienced pharmaceutical executive/scientist with more than 20 years of Pharmaceutical R & D and QA/QC experience. This includes: establishing a state-of-the-art Reference Standards Laboratory of USP, supporting development and registrations of several novel drugs for human and animal health and generic drugs for human healt.

Associate 5

Associate 5

Over 25 years of extensive experience in management and method development and validation, process validation for solids, semi-solids, capsules, injection, and extended release technology, method transfer, CMC submission, QC, biopolymer, contract analytical development , clinical and technical support

Associate 6

Associate 6

More than twenty (20) years of “hands-on-experience” in a variety of technical and manufacturing management positions in the pharmaceutical, medical device and health care industry. Specific areas of expertise in development, operation and validation of pharmaceutical products manufacturing processes and facilities.

Contact Us….

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