Quality System Compliance Support

Synergy Bioscience has always been at the forefront of quality systems compliance and auditing. Our experience has taught us what methods succeed and which ones don’t. A truly effective quality system goes beyond solely focusing on product needs or simply mirroring regulatory requirements in documentation. Instead, it ensures both are adequately addressed without overburdening the involved parties.

Unlike some staffing agencies that simply supply contractor resumes and bill clients, we offer a deep understanding of the industry and the factors that lead to success.

The hallmark of our services is the development of robust and sustainable quality systems. Such systems are essential for delivering reliable, top-tier products and services. Ignoring regulatory feedback, both from the U.S. and globally, can lead to issues like production stops, recalls, and damaged reputations.

Regulatory standards are always evolving, often making it challenging for businesses to keep pace. Many organizations, overwhelmed by these changes, lean on Quality System consultants like Synergy Bioscience. Our legacy lies in our meticulous approach towards creating, refining, and implementing quality systems. We stand as the premier resource for all Quality System queries. Our tailored solutions, drawn from careful listening, are designed to address your specific challenges.

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 Trust Synergy Bioscience with Your Quality System Compliance?

  • We offer bespoke GMP quality management systems, adhering to global standards including FDA, European CE Marking, Canadian Medical Devices, and Japanese Pharmaceutical regulations.
  • Our dedicated teams ensure timely, budget-friendly project completions.
  • We guarantee continuous support, both on-site and remotely.
  • Our consulting fees cover on-site training for your team.

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