- Our experienced teams complete projects on time and within budget while providing continuous on-site and remote support.
- We handle all regulatory submissions (NDAs, ANDAs, BLAs, PMAs, 510(k)) on your behalf and guarantee our commitment until you secure approval.
- We deliver customized GMP quality management systems that comply with global regulatory standards, including FDA, European CE Marking, Health Canada, and PMDA regulations.
QA / RA Consulting
Why Trust Synergy Bioscience with Your Quality System Compliance?
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.
FDA Audit Remediation
Synergy Bioscience is not just another quality system consulting service. We offer real, practical solutions tailored to your specific compliance challenges. Our expertise is not in providing temporary fixes but in ensuring long-lasting compliance that safeguards your business and your customers.
CAPA Investigations
There is a strong link between Quality and Operational Excellence, as a well-established CAPA system most often results in a high ROI and benefits for the business. Failure to establish a compliant and effective CAPA system will damage the progress your organization has made and erode the confidence of the Agency or regulatory authority. Should your organization find itself responding to a Warning Letter or Consent Decree, Synergy Bioscience will develop a robust CAPA Process and train your staff on how to effectively implement it.
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. Let us help you set up a program or review your existing program for compliance with current industry trends.
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 is following the FDA regulations in this regard.
Validation Studies
When it comes to validation, it is always true that the whole is greater than the sum of the parts.
Post market surveillance & MDR
Post-market surveillance (PMS) programs are indispensable in a medical device development plan.
Cleaning Validation
Synergy Bioscience designs and implements robust, compliant cleaning-validation programs aligned with regulatory requirements and best practices. We create risk- and science-based cleaning strategies to eliminate contamination risks that could harm product quality. We produce a complete list of potential residues, cleaning agents, and materials that could contaminate equipment during manufacturing. We develop methods to identify and quantify residues remaining after cleaning, and we perform method development, validation, and residue acceptance-criteria development in our cGMP laboratory. We provide end-to-end cleaning validation support—process validation, scale-up, or remediation—using experienced consultants and state-of-the-art cGMP instrumentation, so you don’t need multiple outside vendors.
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.
Quality System Development
Understanding the needs, requirements, and how to implement a quality system can be a daunting task.
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.
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 any undesirable effect on the product or its packaging.
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.
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.