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- Pharmaceutical Development
- Laboratory Testing
- Quality Compliance Consulting
- Validation Studies
- FDA Pre-Approval Readiness
- Regulatory Filing Services
- Six Sigma Projects
- FDA Inspection Remediation
- Supplier Audits
- Post market surveillance & MDR
- Quality system gap assessment
- Medical Devices Quality System
- cGMP Auditing & Training
- Quality System Development
- Equipment Qualification (IQ/OQ/PQ)
- CAPA Investigations
Pharmaceutical Development
Our pharmaceutical R&D activities span the development continuum from preclinical through post-approval and are customized to address specific development challenges of small molecules and biologics, vaccines, medical devices and companion diagnostics.
Analytical Laboratory Testing
We specialize in testing drug products, drug substances, and nearly all dosage forms including tablets, capsules, semi-solids, sterile, transdermal, and inhalation products. Our mission it to provide you with analytical solutions that will make achieving your drug development goals easier and faster.
Quality Compliance Consulting Services
Most organizations neither have the time, staff, or the resources to keep up with the often subtle changes in regulatory requirements and guidelines, and rely on the expertise of Quality System consultants to ward off troubles. Synergy Bioscience is the leading source of assistance for any issue related to Quality Systems. We listen closely and develop a quality system tailored to your company’s specific needs.
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.
What We Offer
With Synergy Bioscience you get more than good services. You get Quality services you can truly rely on and trust. From early product development and a full scale laboratory testing support, our scientific experts are uniquely qualified to navigate your unique journey, every step of the way. In addition, Synergy Bioscience makes sure that all your quality solutions are implemented properly, with one-on-one coaching for your key staff members.
Our Services
Past Projects
Batch Record Reviews
After receiving an FDA Warning Letter, a well-known pharmaceutical company requested from Synergy to get involved in the remediation of their warning letter.
Chemistry Lab Operation
A CRO/CMO pharmaceutical start up requested from Synergy to help with the set up and initial operation of their chemistry laboratory to support in the development
Cleaning Validation
As part of their cGMP facility operation readiness, a client of ours requested that we develop and validate a cleaning validation program to support their development
Bio Process Validation
A biopharmaceutical company requested from Synergy to work with their engineering department and help in the optimization and revalidation of their manufacturing process
cGMP Facility Transfer
A medical device company, developer and manufacturer of implantable class III medical devices, hired us to help in one of their cGMP facilities transfer.
Supplier Quality Audit
A well-known biotechnology company requested from Synergy to review and improve their Supplier Quality Management system.
CAPA Process
A well know medical devices company was under Consent Decree and in desperate need of special expertise to help them get out of it sooner so they can resume their business.
Our Clients
