Whether you are in the pharmaceutical, medical device, or biotech industry, we welcome the opportunity to serve you. Synergy Bioscience has the capacity and technical expertise to support you meet your product development and manufacturing compliance requirements. Whether you have a need for just a temporary staffing or consulting services to address your medicinal product development or a compliance issue, we are here to help. We guarantee our services that either we will help you meet your product technical and regulatory objectives or our services will be free of charge. Our services include:
- Supporting your quality and regulatory compliance requirements through the establishment of a quality system appropriate for the stage of your product. Our experienced consultants can prepare the right quality manual, standard operating procedures, drug product specifications, and process/method validation protocols. We can also help your organization address any non-compliance issue such as FDA 483, Warning Letter, or a Consent Decree.
- Developing and validating analytical methods for your drug product, whether it is a small chemical molecule or a therapeutic protein molecule. We can also qualify your laboratory equipment (IQ/OQ/PQ) and validate your manufacturing processes and their related computer systems. We work closely with each client to tailor validation projects to their exact needs.
- Establishing effective CAPA process that provides regulatory agencies the confidence that your organization has the ability to self-identify non-compliant issues, identify root causes, determine appropriate corrective actions, and ultimately implement these actions in a timely manner to prevent re-occurrence of the addressed non-conformity. We have a proven track record of success in establishing, maintaining, and providing training on a robust and effective CAPA process that will keep your business compliant, so you don’t have to worry about incoming FDA inspections and you can focus on the business profitability.
- Performing Supplier Qualification Audits as well as Pre-Approval Inspection (PAI) readiness to ensure the compliance of your cGMP System with the regulatory requirements. It is important to perform a reality check on your compliance situation before the FDA walks through the doors of your organization. The use of a third-party expert allows for a more objective evaluation of the entire process from a fresh pair of eyes that can offer an objective comparison against current industry standards.
At Synergy Bioscience, we challenge ourselves to a higher standard — a global standard, using global practices to reach global markets. Achieving that level of excellence begins with listening intently to your issues and designing strategies rooted in our experience to guide you through the regulatory complexities and provide successful results.
With Synergy Bioscience you get more than good consulting services. We make sure that all of your Quality solutions are compliant, practical, and implemented properly, with one-on-one coaching for your key staff members.
What We Can Offer You
- Quality Systems Development and Optimization
- Consent Decree & Warning Letter Remediation
- Quality System Gap Assessment
- Laboratory & Manufacturing Equipment Qualification (IQ/OQ/PQ)
- CAPA & Root Cause Analysis Process Establishment
- cGMP Auditing & Training
- Supplier Audits & Qualifications
- Post-Market Surveillance & MDR & Recalls
- Six Sigma & Continuous Improvement Projects
- Cleanroom & Water System Validations
- Computer System & Software Validation
- Sterilization Process Validation
- Biologics Downstream Process Validation
- Manufacturing Process Validation
- Structural Chemistry Studies using LC-MS & GC-MS
- Pharmaceutical Dissolutions & Stability Studies
- Solid Dose & Injectables Process Validations
- Drug Product Extractable/Leachable Studies
- Analytical Method Development / Validation
- Chemistry, Manufacturing, and Control (CMC)
- Pharmaceutical Batch Record Development
- Lyophilization (Freeze Drying) Process Validation
- Therapeutic Protein Purification & Characterization
- Manufacturing Equipment Cleaning Validation
- Pre-Approval Inspection Support
- cGLP / cGCP / cGMP Compliance Support
- 21 CFR Part 11 Compliance Support
- IND/NDA/BLA/ANDA Applications Support