Technical Services
Our teams are comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards.
This enables us to offer the best-in-class technical services solutions. We take pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
Engineering
Our Engineering Services include:
Process Design – Using information acquired during development to optimize a process that consistently delivers a product that meets its Quality attributes.
Cleaning systems & cleaning process design and cycle development
Cleaning chemistry characterization and optimization
Equipment Design
Technology transfer and product scale-up
Implementation of Disposable Technologies
Continuous Manufacturing engineering support in all functional areas (Media, Buffer, Fermentation/Cell Culture, CIP/COP, Utilities, HVAC, EMS/BMS)
Design Assist
Design Review
Project Controls
Facility Engineering Support
Plant Startup
Reliability Engineering
Project/Program Management
AM fully adopts the owner-advocate model where we protect your interest first, we utilize LEAN principles to deliver high value productivity, and we know how to ensure alignment of FDA requirements and industry standards with the site/client procedures established. We operate on the mindset that we need to deliver on all three: Cost, Quality and Schedule.
We know the highest risk to any project is poor communication, leading to costly dollar overruns, change orders, and disrupted plans. We have proven tools, communication strategies, and best known methods to assure proactive addressing of work elements before they negatively impact project objectives.
Our Project / Program Management management services include:
Owner’s Advocate/ Owner’s Rep consultation to ensure meeting your cost, quality and schedule objectives
Pre-project planning through closeout inclusive of turn-over packages for efficient execution
Comprehensive CQV forward planning to proactively reduce future risks and avoid cost overruns
Integrated CQV project delivery to ensure time to market
Project Controls and Scheduling Services
Program Planning
Risk Management
Quality and Regulatory
Do you lack Quality or Regulatory expertise? Need more resources to attain a Quality or Regulatory goal or directive? Do you need Quality or Regulatory insight? Or, do you just need to consult with a team that has years of Quality and Regulatory experience? No matter what your needs may be, AMTS can provide you with the utmost service to meet your needs. We offer the following:
QC Methods
Development
Batch Record Review
Batch Disposition and Release
Internal and External Auditing
Quality Specialist Support
Quality Control
Change Management
Deviation Support
Documentation & Control
Training
Other Quality areas where assistance is provided:
Perform sampling and inspection
Inventory updates to reflect material status (HOLD, APPROVED, REJECT, QUARANTINE)
Ensure that material certifications (i.e. Certificate of Compliance) comply with current registrations and any pertinent business requirements
Perform sampling and inspection for identity of incoming unlabeled material
Issuance and inventory control of labels and printed material (for product manufacturing and packaging)
Perform AQL sample requests, inspections, document results
Perform review of AQL sampling documentation
Manage acceptance plan process
Regulatory Specific
CMC Regulatory Filing
Regulatory Compliance
Regulatory Intelligence
Regulatory Consulting
Regulatory Support
Mock Audits
Input on Filing Strategy
Clinical Trial Guidance
Warning Letter Guidance
Insight on Post-Approval Requirements
ANDA Submissions
Decommissioning
AM Technical Solutions offers full turnkey solutions for the decommissioning of manufacturing processes and facilities. We focus on the quality compliance aspect, while meeting schedule and cost. Our team is experienced in all facets of a decommissioning program and will utilize our knowledge and expertise to provide you with industry-leading solutions. As part of our full turnkey solution the following are high level activities that our team can provide:
Decommissioning Program Development and Program Management
Decommissioning program protocol generation and execution
- [Quality System Reconciliation
- [Facility and Maintenance Reconciliation
- [Financial Reconciliation
- [Equipment and Process Final Run close out
- [Prep Equipment for decommission in place or removal
Oversight, Demolition and Removal of Equipment, as well as any utilities and architectural modifications
Manage resale or disposal of equipment
Operational Readiness and Sustaining Support
With any Process remediation and/or optimization or Plant Start-up, site operations must include some level of planning to ensure the changes are properly implemented. But, the best operations will carefully integrate a robust Operational Readiness and Plant Startup program. These projects must be closely coordinated and cross-functionally integrated with all departments involved, due to the complexity of regulatory, operational and quality deliverables. AM Technical Solutions has a proven track record for providing Operational Readiness and Plant Start-up program development, support and implementation that is rolled out to or in collaboration with the end users with nothing but 100% customer satisfaction as a result.
For us, Early Quality Integration (EQI) is integral to executing a flawless Operational Readiness and Plant Startup project. AM Technical Solutions fully adopts the owner-advocate model where we protect your interest first, we utilize LEAN principles to deliver high value productivity, and we know how to meet all FDA requirements. We have a network of valuable resources and relationships to reduce procurement costs, and ensure timely completion.
Our Operational Readiness & Plant Startup services include:
Tech Transfer
Document Remediation
Standard Operating Procedure (SOP) and program documentation development
Process Remediation & Design
Process Optimization
Operational Optimization & Operational Excellence
SchedulePro & SuperPro Implementation
Quality System Remediation & Implementation
Automation Program Support
MFG Engineering and Sustaining Support
Documentation Control and Training
CMMS Administration
CMO Site Support
Technical Writing Program Development
Specialist Services
AM Technical Solutions, having over 25 years servicing the Life Sciences industry understand the inherent challenges with designing, building, commissioning, plant start-up, and sustaining operations. In addition to the logistical and financial challenges there is a common theme with the majority of Life Sciences firms that are looking to excel and set themselves apart from the competition: That never-ending mission to identify and hold onto industry leading, and talented Specialist professionals to support your organization.
Our industry leading professionals have lived through these challenges, understand the pain points, and know exactly what it is to make your operation a success. We approach every project with our client’s best interest at the forefront of everything we do, and we have a wide array of services that fit your needs including some of the most hard to come by specialty skillsets.
Cost, Planning & Scheduling
Quality Program Development
Program Management
Environmental, Health & Safety
Safety Leadership and Training
Owner’s Representative Services
Technical Project Managers
Computer Systems Validation
NEBB Certification & Performance