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 information online regarding
regulatory submission management (term considered too vague
by the International Bureau - Rule 13 (2) (b) of the
Regulations); 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
consulting services in the field of regulatory submission
management to medical companies to assist them with
applications for drug and medical device approval (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations); 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, namely, 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 (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations); business consulting and for
companies in the life sciences fields for use in the
following applications, namely, supply chain management
(term considered too vague by the International Bureau -
Rule 13 (2) (b) of the Regulations), including, internet of
medical things (IoMT), connected service and quality
management, product lifecycle management, product master
management, and enterprise resource planning (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations); 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 (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); business consulting and management for
companies in the life sciences fields for use in the
following applications, namely, 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); business consulting and management for
companies in the life sciences fields for use in the
following applications, namely, 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 (term considered too vague
by the International Bureau - Rule 13 (2) (b) of the
Regulations); providing quality and IT staffing solutions
for companies in the life sciences fields, including
staffing augmentation services and onsite and remote
on-demand compliance staff augmentation (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); 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 (term considered too vague by the International
Bureau - Rule 13 (2) (b) of the Regulations)
41
Providing educational and informational content and
customized training materials and programs 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, namely, regulatory issues and
developments, GxP (Good Practice) compliance,risk management
(term considered too vague by the International Bureau -
Rule 13 (2) (b) of the Regulations), design control (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations), QMS (Quality Management
Solutions) (term considered too vague by the International
Bureau - Rule 13 (2) (b) of the Regulations), CSV (Computer
System Validation) (term considered too vague by the
International Bureau - Rule 13 (2) (b) of the Regulations),
SOP (Standard Operating Procedures) (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations), Data Integrity (term considered too vague by
the International Bureau - Rule 13 (2) (b) of the
Regulations), UDI (Unique Device Identification) (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations), regulatory readiness, and other
related practice areas in the life sciences fields (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations)
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, and 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
product approval for commercial purposes (term considered
too vague by the International Bureau - Rule 13 (2) (b) of
the Regulations); consulting services in the field of cloud
computing in the field of life science; providing technical
regulatory affair consulting services directed to medical,
medical technology, biopharmaceutical, and biotechnology
companies in order to assure compliance with food and drug
administration's laws and regulations (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, namely, enterprise systems
(term considered too vague by the International Bureau -
Rule 13 (2) (b) of the Regulations), 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,
namely, regulation support (term considered too vague by the
International Bureau - Rule 13 (2) (b) of the Regulations),
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, namely, supply
chain management (term considered too vague by the
International Bureau - Rule 13 (2) (b) of the Regulations),
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 (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations), 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,
namely, 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, namely, 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, namely, management (term considered
too vague by the International Bureau - Rule 13 (2) (b) of
the Regulations), 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, and regulatory compliance consulting in the
fields of biologics, pharmaceuticals, prescription drugs and
medical devices