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.

FDA Audit Remediation

Transform Your Quality Compliance with Synergy Bioscience

In the highly regulated world of medical devices, a single FDA audit revealing noncompliance can have catastrophic consequences…

CAPA Investigations

A CAPA system is not only a regulatory requirement; it makes good-business sense to pharmaceutical and other life science companies. An effective CAPA process is capable…

CAPA Investigations

A CAPA system is not only a regulatory requirement; it makes good-business sense to pharmaceutical and other life science companies. An effective CAPA process is capable…

Process Validation

Process validation has been a major focus of the FDA in recent years. Our team has extensive experience in both setting up and monitoring process validation programs…

Computer System Validation

The process of ensuring compliance with 21 CFR Part 11 has always been a challenge for life science companies, as it requires unquestionable evidence that the organization…

Computer System Validation

The process of ensuring compliance with 21 CFR Part 11 has always been a challenge for life science companies, as it requires unquestionable evidence that the organization…

Validation Studies

When it comes to validation, it is always true that the whole is greater than the sum of the parts. When the proper relationships between validation and the other firm’s activities are established…

Cleaning Validation

  • Do you know what are the various elements of a cleaning validation program?
  • How do you know if these elements have been established…

Cleaning Validation

  • Do you know what are the various elements of a cleaning validation program?
  • How do you know if these elements have been established…

Post market surveillance & MDR

POST-MARKET SURVEILLANCE AND MEDICAL DEVICE REPORTING

Post-market surveillance (PMS) programs are indispensable in a medical device development plan. It is a regulatory requirement…

Equipment Qualification (IQ/OQ/PQ)

Many companies assume that since process validation does not have to be completed until your product nears market production, the same is true for equipment qualification…

Equipment Qualification (IQ/OQ/PQ)

Many companies assume that since process validation does not have to be completed until your product nears market production, the same is true for equipment qualification…

Supplier Audits

If your current internal audit program consists of employees tied to your organization ₋₋your internal audit has already failed. It is virtually impossible for an in-house auditor…

Quality System Development

Understanding the needs, requirements, and how to implement a quality system can be a daunting task. Organizations waste a great deal of time and money in trying to understand…

Quality System Development

Understanding the needs, requirements, and how to implement a quality system can be a daunting task. Organizations waste a great deal of time and money in trying to understand…

Quality system gap assessment

The QMS Gap Assessment is critical to ensure product development and manufacturing meets the regulatory requirements as a condition for a successful commercialization…

cGMP Auditing & Training

Synergy provides cost-effective training programs and materials for regulatory compliance. We develop and produce customized, competency-based training courses, designed…

cGMP Auditing & Training

Synergy provides cost-effective training programs and materials for regulatory compliance. We develop and produce customized, competency-based training courses, designed…

Sterilization process validation

The objective of the sterilization process validation is to determine that the manufacturer’s current sterilization process can consistently achieve sterility and does not cause…

Cleanroom & Water System Validations

A cleanroom is a controlled environment where the concentration and size of airborne particles per cubic meter (or per cubic foot) are tightly regulated. Cleanrooms are indispensable…

Cleanroom & Water System Validations

A cleanroom is a controlled environment where the concentration and size of airborne particles per cubic meter (or per cubic foot) are tightly regulated. Cleanrooms are indispensable…

FDA Pre-Approval Readiness

After many years of hard work, and coordination between different departments and outsourcing activities, you submitted your application to the FDA for approval. How you can ensure…

Regulatory Filing Services

The contents of a regulatory submission convey the first impression the FDA will have of your product and the quality and professionalism of your organization. It has been proven consistently…

Regulatory Filing Services

The contents of a regulatory submission convey the first impression the FDA will have of your product and the quality and professionalism of your organization. It has been proven consistently…

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