Quality Compliance Consulting

Our Quality Compliance Services are robust and sustainable quality systems that are the key to producing safe, consistently reliable, high-quality products and services. Unfortunately, not addressing inspection findings of regulatory authorities both in the United States and around the world can leave your company exposed to production halts, recalls, import bans, detention or production seizure— which can severely damage your organization’s product pipeline, financial health, and on-going reputation.

At Synergy Bioscience, we know full well the propensity of both national and international regulatory agencies to continually “raise the bar” in the name of needing more authority to protect proper safety. Most organizations neither have the time, staff,resources, or the interest in keeping up with the often subtle changes and regional interpretations that occur in guidelines, and rely on the expertise of Quality System consultants to ward off trouble. This is where Synergy Bioscience raises your bar–bringing their unparalleled experience and attention to detail in creating, reviewing, implementing and remediating Quality Systems for a host of organizations for generations. Synergy Bioscience is the leading source of assistance for any question or issues related to Quality Systems. We listen closely and develop a quality system tailored to your company’s specific needs. Synergy Bioscience’s expertise and pragmatic approach will help you address your most pressing issues.

Synergy Bioscience has

  • Helped over 27 companies achieve FDA, EU, Health Canada or ISO compliance
  • Submitted over 13 ANDA/NDA/BLA applications
  • Implemented over 18 complete quality systems.

Let Synergy Bioscience help you with any of the following consulting services

  • Quality System development for certification/accreditation
  • Quality System improvement/remediation for re-certification.
  • Establishment and maintenance of a Corrective Action Preventive Action program (CAPA)
  • Risk Analysis/ Management
  • Development of a Change Management/Document Control System
  • Establishment of a Supplier Audit Program
  • Establishment and Implementation of an effective training program.
  • Provision of Software solutions for managing your quality systems
  • Preparation of FDA Pre-Approval Inspection (PAI) and cGMP compliance
  • Composition/Execution of Validation studies (analytical method, process, equipment, software and cleaning)
  • Development and Implementation of FDA Audit response to Form 483s, warning letters, and Consent Decrees.

Why select Synergy Bioscience as your consulting company?

  • All of our GMP quality management systems are fully customized solutions, which are fully compliant with all FDA Quality System regulations. They also meet the full compliance of the European CE Marking, Canadian Medical Devices regulations, and Japanese Pharmaceutical Affairs Law and MHLW Ordinance#169 (if needed).
  • Our FDA GMP consulting and project management teams strive to work together to deliver your quality system on-time and within budget.
  • It’s our business to always be accessible to you, and provide unlimited support during your project either on-site or off-site.
  • On-site on-the-job-training for your employees is included in our FDA GMP consulting fees.

To discuss how Synergy Bioscience can help you, please contact us.