REGULATORY COMPLIANCE SERVICES
Let Cogent help your organization avoid issues with regulatory agencies.
- Mock FDA inspections
- FDA action remediation
- FDA submission assistance
- Supplier and outsourcing qualification
- Pre-approval inspections (PAI)
- Documentation and Change Management
Cogent Professionals offers innovative approaches to partnering with its clients. One of these innovative approaches is insourcing the Sample Management Services. In this model, Cogent is responsible for recruiting, hiring, providing benefits, and managing the insourced staff. Cogent assigns a leadership team and co-develops a workflow with its clients to ensure the tasks are conducted with efficiency, accuracy, safety, and quality. By insourcing your sample management team, you are expanding your capabilities the way you use outsourced services, but embedded within your facility working alongside your staff. This model offers many advantages for those companies considering it, including:
- Improves turn-around times by rapidly adapting to changing project needs;
- Provides flexibility of adding or reducing human resources as needed in terms of numbers, schedule, and skill set;
- Frees your team to focus on core business matters;
- Provides 3rd party management of sample storage, management and preparation to ensure quality.
QUALITY CONTROL/ QUALITY ASSURANCE SERVICES
- QC/QA workforce strategies
- Correction and preventative action (CAPA) planning and execution
- Policy, SOP & Batch record review
- Third party GMP/GLP consulting, auditing and training
All your projects are important. There are those projects that are just big enough that your current staff cannot take the time to manage. Cogent can help with these important projects by staffing it with an experienced Project Manager.
In our experience without proper oversight and constant management of deliverables and milestones, projects too often are delayed or over budget or both. A Cogent Project Manager can help with the following tasks:
- Define your statement of work and scope
- Build a realistic schedule
- Meet the team members assigned to the project and understand their strengths and bandwidth
- Identify where and when you’ll need external help, and secure it
- Develop an implementation plan for the project’s milestones and outcomes
Cogent provides you with a knowledgeable project manager with experience in:
- Engaging internal team members and assembling external members
- Building Project Scopes or Statements of Work
- Providing ongoing guidance and direction during the implementation and build phases
- Recalibrating resources based on needs, goals and budget
- Providing accountable results
Phone: (317) 454-8080
101 W. Ohio St, Suite 1500
Indianapolis, IN 46204
Learn more about our services and contact us today to see how we can help your business achieve its full potential.
- Laboratory Support
- Recruiting Services
- BPO Services
- Strategic Consulting
If you are ready to engage with Cogent, or you simply have questions on our solutions, complete the easy form below and we will respond within 24 hours.