Maynard
Consulting Co.
SERVICES
Full range of services across the globe
Our international reach combined with our depth of resources and personal service provides unique advantages to our clients. Dedicated corporate resources enable Maynard Consulting to provide knowledge and support unparalleled in Life Sciences, Auditing, IT, and Biotechnology.
Quality Assurance
MCC's quality assurance consultants provide knowledge, strategies, remediation, warning letter, consent decree and recall support; root cause investigation, complaint, CAPA and deviation management; gap assessment, risk management and change control; and develop methodologies, policies, quality systems, training and documentation.
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Project Management
Effective on-site project management controls the scope and project costs, ensures reliable delivery of services, allows for innovation and reduces clients overall exposure to risk.
Our managers use project tools to assist in managing project activities as well as keeping the client updated on the projects progression.
IT CONSULTING
Balancing structure and creativity our services are designed to help our customers find solutions where technology, people and processes achieve overall IT strategy. Independent and completely vendor or technology agnostic our aim is to help our customers define strategy and drive execution across a range of IT related areas.
Through our networks of specialist consultants we can work with customers to achieve ROI, drive innovation, minimize business risk and create value. We can also align our consultancy services to others offered by us to deliver specialist training, staff augmentation and interim executive support where necessary to help fill gaps in new organisational structure until permanent positions are established.
IT Assessment Services
IT Outsourcing - Strategy, RFP and Transition
IT Cost Modeling and Financial Analysis
TEM (Telecom Expense Management)
IT Organizational Design
IT Strategy & transformation
Vendor Management Strategy
IT Service Management Strategy
IT Governance - strategy and implementation
Enterprise Software Selection and Implementation
Auditing
MCC offers GMP and GCP audits to assure that pharmaceuticals, biologics, and medical devices are produced consistently and are strictly controlled to meet both national and international standards appropriate for their intended use. MCC assists clients to ensure that related regulatory requirements (FDA, NF, MHRA) are met in their manufacturing site as well as for their foreign and domestic suppliers and vendors. MCC provides auditing solutions for all types of medicines, biologics, and medicals devices. MCC also provides both foreign and domestic supplier and vendor qualification and auditing services for their clients.
Pharmaceutical Auditing Services:
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GMP Auditing
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GMP Shared Audits
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GCP Clinical Auditing
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GLP Auditing
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Supplier and Vendor Auditing
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Supplier and Vendor Qualification
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Pharmaceutical Auditing Approach
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Pharmaceutical Auditing for OTC Drugs
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Pharmaceutical Inspection
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Quality Assurance Services
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Supply Chain Program Management
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Business Assurance
21 CFR PART 11
MCC Validation can help you understand and implement a risk-based approach to compliance with 21CFR Part 11, rooted in the Final Guidance for Scope and Application provided by FDA.
Our experience will help you determine the Part 11 relevance to your processes.
Our staff maintains certification and ongoing education to be able to provide advice in which you can be confident.
MCC Validation can provide all phases of activities needed for compliance with this regulation from gap-analyses and remediation planning for existing systems to prospective assessments of new systems.
Regulatory & Compliance Consultants
MCC delivers strategies to clients who need them for regulatory and compliance projects.
We have a national network of senior quality, validation, and compliance experts.
Our network offers experienced consultants to assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, cGMP compliance auditing, and system issues, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations.
Our consulting expertise includes:
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Quality Assurance & Quality Engineering. Development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control. Methodology, policy, and procedure development. Gap/Risk assessment. Recalls, MDR’s and complaint handling. Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 11, quality systems, vendors, and IT compliance.
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Regulatory Affairs. Writing submissions, documentation, and remediation including 510k submissions, AER's, PMA’s, IDE, remediation/resolution management, technical papers and complaint handling.
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Validation. Developing Standard Operating Procedures (SOP), Validation Support Processes (VSP), validation protocols (IQ, OQ, PQ), and validation master plans. Conducting validation executions and writing validation reports. Computer systems, software, process, cleaning, methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11.