Regulatory Affairs Consultants

Our FDA Regulatory Affairs, ISO 13485 and HACCP consultants have worked with all levels of the 510k process in biological, pharmaceutical, Nutraceuticals, cosmetic and medical device companies to help them achieve international quality requirements and regulatory approvals.  Our expertise includes: regulatory affairs, risk management, quality metric development, clinical design, environmental and waste systems, training, clean room technology, product design, manufacturing and facility design, testing, pre-FDA auditing / inspections, quality, pharmacology/toxicology, project management, and due diligence.

We assist companies to achieve and sustain compliance.  Our Services include:

  • Regulatory Strategy
  • cGMP Documentation / SOP Writing
  • HACCP Documentation and Processes
  • ISO 13485 and ISO 9001 certification preparation
  • Registration and Submissions  -  U.S., Canada, Europe, Asia, & Latin America
    • Including, but not limited to,: 510(k), IND, IDE, NDA, ANDA, NDS, and PMA
  • Regulatory Compliance and Registration
  • Risk Management Strategy and Systems
    • Design  & Process Failure Mode and Effects Analysis (FMEA)
    • Hazard Analysis
  • Product Design & Development (Pharmaceuticals, Cosmetics, Nutraceuticals, Medical devices-Class I to III)
  • Equipment, Process Validation
  • Due Diligence (Technical, Regulatory, and Business)
  • FDA and ISO Audit Support
  • Product and Packaging Labeling
  • Software Validation

Using Kevin Kennedy Associates’ 600+ experts in science, quality, processes, software manufacturing, training, culture management, formulation, facility and equipment design, marketing and packaging along with business, planning KKA can provide an interdisciplinary team to meet all your needs.


Let us quickly locate the best and most qualified expert or expertise you need.


Full Name*
Please fill in the required field.

Please fill in the required field.

Please fill in the required field.

Please fill in the required field.

Client Need
Please fill in the required field.

Invalid Input


Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.


  • Poly(methylmethacrylate) Manufacturing Operations / Processes Consultants
  • Cell Phone Technologies Expert


Our Business Model
At Kevin Kennedy Associates, we’ve revolutionized the consulting business by streamlining the way our clients interact with experts.