35
Advisory, development, and strategic planning services
provided to companies for business purposes in the life
sciences industries; business consultation services in the
field of gxp compliance; business consulting services on
processes and workflows related to content creation,
localization and publishing strategy including translation
memory and terminology management, quality management, life
sciences regulatory compliance and risk management; business
consulting and management in the field of clinical trials,
namely, clinical data and regulatory submission management
on behalf of medical, biopharmaceutical and biotechnology
companies to assist them with clinical research, clinical
trials and applications for drug approval; regulatory
submission management, namely, assisting others in preparing
and filing applications for new medical devices, medical
technologies, medications, biopharmaceuticals, and
biotechnology with governmental regulatory bodies around the
world; regulatory submission management, namely, providing
simultaneous multiple country submissions of applications
for the registration and approval of medical devices,
medical technologies, medications, biopharmaceuticals, and
biotechnology; providing online business information
regarding regulatory submission management; business
management consulting, strategic planning and business
advisory services provided to medical, medical technology,
biopharmaceutical, and biotechnology companies, and
government agencies, educational and research institutions,
law firms, and investment firms in the fields of biologics,
pharmaceuticals and medical devices; providing business
consulting services in the field of regulatory submission
management to medical companies to assist them with
applications for drug and medical device approval;
regulatory submission management, namely, assisting others
in preparing and filing applications for new drugs and
medical devices with governmental regulatory bodies;
business consulting services in the field of biologics,
pharmaceuticals, prescription drugs and medical devices;
business consulting and management for companies in the life
sciences fields for use in the following applications:
regulation support, including standard operating procedures,
customized compliance training programs, compliance as
service (caas), medical device cybersecurity, medical device
compliance, data integrity, serialization/track and trace,
global unique device identification, good clinical practice
(gcp) compliance and quality assurance, drug safety,
pharmacovigilance (pv), risk-based monitoring, auditing as a
service (aaas), risk management, remediation planning and
execution, emerging companies compliance road mapping, eu
mdr and ivdr compliance, and audits and assessments;
business consulting and management for companies in the life
sciences fields for use in the following applications:
supply chain management, including, internet of medical
things (iomt), connected service and quality management,
product lifecycle management, product master management, and
enterprise resource planning; business consulting and
management for companies in the life sciences fields for use
in the following applications: validation and qualification,
including, computer software assurance, manufacturing system
validation, laboratory equipment and instrumentation,
process validation and cleaning validation, laboratory
information management systems (lims), facilities and
utilities, and manufacturing systems; business consulting
and management for companies in the life sciences fields for
use in the following applications: compliance strategy,
including laboratory validation, assessments, strategy and
remediation planning, performing remediation activities, and
providing advisory services to assist gxp labs in meeting
commercial and regulatory requirements; business consulting
and management for companies in the life sciences fields for
use in the following applications: digital transformation
strategy, including support on demand services, development
on demand services; business consulting and management for
companies in the life sciences fields for use in the
following applications: management, including life sciences
and program management, gxp cloud services, and
organizational change management; providing information in
the area of global sustainable business solutions for
companies in the life sciences fields; business consulting
and management for companies in the life sciences fields for
use in the following applications: enterprise systems,
including enterprise content management, cloud-based data
migration, quality document management systems, enterprise
quality management, learning management systems, and
electronic lab notebooks
41
Providing educational information and production of
customized training materials in the life science fields
through various print and electronic multimedia, including:
videos, blogs, articles, webinars, white papers,
onsite/offsite remote channels, workshops, hands-on training
programs, and other training environments in the life
sciences fields, including but not limited to the following
subject matter: regulatory issues and developments, GxP
(Good Practice) compliance, risk management, design control,
QMS (Quality Management Solutions), CSV (Computer system
Validation), SOP (Standard Operating Procedures), data
integrity, UDI (Unique Device Identification), regulatory
readiness, and other related practice areas in the life
sciences fields
42
Consulting services in the fields of biotechnology,
pharmaceutical research and development and genetic science;
consulting services in the fields of biotechnology,
pharmaceutical research and development, quality
manufacturing, information technology, and computer aided
design; consulting services for others in the field of
designing pre-clinical and clinical studies and trials for
others; product research and development for others in the
fields of biologics, pharmaceuticals, prescription drugs and
medical devices; quality management services, namely,
quality evaluation and analysis, quality assurance and
quality control in the field of biologics, pharmaceuticals,
prescription drugs and medical devices; scientific
consulting and research services relating to the field of
pharmaceuticals, medical devices, and life sciences, namely,
biology, and medicine; consulting services in the fields of
biotechnology and pharmaceuticals, namely, design,
development, technical verification and technical validation
of manufacturing and filling processes, drug formulations,
testing protocols and analytical methods; scientific and
technological services, namely, scientific research,
analysis, testing, and related scientific studies in the
field of chemistry and molecular biology, namely, biologics
and protein detection, characterization, analysis and
testing; consulting services in the field of medical device
certification [quality control]; consulting services in the
field of cloud computing in the field of life science;
providing technological consultancy in the field of medical
technology, biopharmaceutical technology, and biotechnology
for companies in order to assure compliance with food and
drug administration's laws and regulations; technical and
scientific consulting and management for companies in the
life sciences fields for use in the following applications:
enterprise systems, including enterprise content management,
cloud-based data migration, quality document management
systems, enterprise quality management, learning management
systems, and electronic lab notebooks (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); technical and scientific consulting and
management for companies in the life sciences fields for use
in the following applications: regulation support, including
standard operating procedures, customized compliance
training programs, clinical compliance as service (caas),
medical device cybersecurity, medical device compliance,
data integrity, serialization/track and trace, global unique
device identification, good clinical practice (gcp)
compliance and quality assurance, risk-based monitoring,
auditing as a service (aaas), risk management, remediation
planning and execution, emerging companies compliance
roadmapping, eu mdr and ivdr compliance, and audits and
assessments (term considered too vague by the International
Bureau - Rule 13 (2) (b) of the Regulations); technical and
management for companies in the life sciences fields for use
in the following applications: supply chain management,
including, internet of medical things (iomt), connected
service and quality management, product lifecycle
management, product master data management, and enterprise
resource planning (term considered too vague by the
International Bureau - Rule 13 (2) (b) of the Regulations);
technical and scientific consulting and management for
companies in the life sciences fields for use in the
following applications: validation and qualification,
including, computer software assurance, manufacturing system
validation, laboratory equipment and instrumentation,
process validation and cleaning validation, laboratory
information management systems (lims), facilities and
utilities, and manufacturing systems (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); technical and scientific consulting and
management for companies in the life sciences fields for use
in the following applications: compliance strategy,
including laboratory validation, assessments, strategy and
remediation planning, performing remediation activities, and
providing advisory services to assist gxp labs in meeting
commercial and regulatory requirements (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); technical and scientific consulting and
management for companies in the life sciences fields for use
in the following applications: digital transformation
strategy, including support on demand services, development
on demand services (term considered too vague by the
International Bureau - Rule 13 (2) (b) of the Regulations);
technical and scientific consulting and management for
companies in the life sciences fields for use in the
following applications: management, including life sciences
and program management, gxp cloud services, and
organizational change management (ocm) (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations)
45
Regulatory compliance consulting services in the life
sciences fields, namely, reviewing standards and practices
to assist clients with compliance with governmental laws,
regulations and rules pertaining to medical devices, medical
technologies, medications, biopharmaceuticals, and
biotechnology; provision of information online pertaining to
regulatory compliance in the fields of medical devices,
medical technologies, medications, biopharmaceuticals, and
biotechnology; regulatory compliance consulting in the
fields of biologics, pharmaceuticals, prescription drugs and
medical devices
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