Quality Assurance & Regulatory Compliance
Develop and implement a Quality Management System addressing all applicable U.S. and Global Regulatory Requirements.
On-site and remote auditing services. Identifying any compliance gaps between your systems and the constantly changing international regulatory requirements.
Provide expertise for the regulatory pathways for manufacturers and importers that want to market their products in the U.S.
Project &Risk Management
Assess changes for their impact on both your quality system and your products.
Ensure that complex projects are completed on time and to desired quality standards.
Gap Analysis, Remediation and Implementation Plan.
Audit readiness (Agency and ISO) Mock Audits (FDA, EU)
Supplier Audit Program Management. Quality Systems Compliance Audits.
Supplier Qualification Audits (CMO, CRO, API, Supply Chain, Distributor, Laboratory, Testing Services)
Define the clinical strategy most appropriate for your product and its intended use.
Support clinical trials and post-market studies.
Planning and developing the supplier/vendor management policy, program and procedures. Selecting vendors, negotiating contracts, and reducing risks.
Gap Assessment & Remediation
Identify significant system gaps and bring your process into compliance. Remediation activities associated to FDA 483's and Warning Letters.
Qualification & Validation
Full-service computer software, equipment, facility and processes qualification and validation in life sciences regulated environments.
User Requirements and Functional Specification
Expertise and guidance to transfer knowledge between development and manufacturing or to new or upgraded facilities.
Customized training programs. Up-to-date on the rapidly changing regulatory landscape. Comprehensive GxP training programs. Specialized expertise.
75 State Street, Ste. 100
Boston, MA 02109