Internal and External Audits
Conduct Audits, to applicable standards, on behalf of Customers, to their operations (Internal Audits) and to Third Parties (e.g. Suppliers). Standards may include FDA Title 21CFR 820, 21 CFR 211, ISO 13485, others
Compliance Training
Conduct needs assessment and conduct training in the fields of Regulatory Compliance. Fields may include 21CFR 820, 21 CFR 211, ISO 13485, others
Process, Systems, Product Validation
Validations (IOQ) Protocols review, preparation and support. Regulatory Compliance evaluation of Validation Plans and Reports.
Supplier Qualification
Conduct assessments of Potential Suppliers in order to qualify them as providers of materials or services to Customer Accounts. Quality systems audits, process audits, capabilities studies and other services offered.
Third-party Certification Project
Perform the functions of Third Party Certifiers of processes and product release under Regulatory Mandate. Representation to Regulatory Agencies on the Customer Account’s behalf. Provide support personnel to maintain operations continuity during this scenario.
Corrective And Preventive Action (CAPA) Quality Systems
Assessment of CAPA quality systems to Regulatory Compliance standards. Conduct Gap analysis and recommend remedial actions. Development of Quality systems elements, Policies & Procedures and training.
Engineering Solutions
Provide technical support and training on various process improvement and engineering tools as SMED, Value Stream Mapping, Project Management, Six Sigma Tools, etc.
Regulatory Audits Remediation Services
Facilitate resources to assure completion of identified remediation tasks and sub-projects. Our consultants would assist firms (clients) in assuring that all regulatory compliance issues are adequately resolved through a structured process of planning, progress monitoring and reporting.
Local, Federal & International Regulatory Advisors
Provide Guidance and assess compliance to Local, Federal and International Regulatory agencies.
Consent Decree Negotiation
Representation to Regulatory Agencies on Customer Account’s behalf.
Placement and Recruitment
We have always provided scientific, technical, executive and management staffing services locally, and throughout the US. We specialize in:
- Validation, Quality & Regulatory Compliance
- Engineering
- Management
- IT, Integration, Automation and Software Development
- Manufacturing
- Laboratory
- Procurement and Planning
- Project Managers
We are industry experts with a strong network and contacts database to immediately have access to the best industry professionals.
Our success in identifying the most qualified resources in the life sciences industries is derived from our leadership, network and active involvement in the industry. Our professional service business gives us access and the opportunity to directly interact with top rated industry professionals on the job marketplace.
Placement Objectives
Our primary goal is to assist our clients with building the strongest teams possible. Because of our daily interaction with our clients, we exactly know our clients' staffing needs and we profile the skills and background required for a specific vacancy. We always have candidates at hand, pre-screened and pre-qualified to be recommended to better suit our customer’s requirements.
We also provide the following options:
Contract to Hire
Contract Services
