35
Business 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 (good practice) 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; 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;
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 pertaining to business operations including
standard operating procedures, audits and assessments;
business consulting and for companies in the life sciences
fields related to supply chain management, including
internet of medical things (iomt), connected service and
quality management, product lifecycle management, product
master management, and enterprise resource planning;
providing quality and it staffing services for companies in
the life sciences fields and employment consultation
pertaining to staffing augmentation services and onsite and
remote on-demand compliance staff augmentation; business
consulting and management for companies in the life sciences
fields pertaining to business operations including
information and data compiling and analyzing relating to
business management; consulting services in the field of
medical device product approval for commercial purposes;
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
41
Providing educational programs in the life science fields
using on-line activities, non-downloadable webinars and
blogs, workshops, and printable materials distributed
therewith featuring 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;
biotechnology research consulting services; pharmaceutical
research and product development for use in manufacturing;
information technology consultation services; computer aided
design services; 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; design and development and technical
verification consulting services in the fields of
biotechnology and pharmaceutical research, 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; computer consulting services in the field of cloud
computing in the field of life science; technical and
scientific research consulting and computer project
management for companies in the life sciences fields
pertaining to cloud-based data migration; technical and
scientific consulting and management for companies in the
life sciences fields pertaining to technical verification
and validation laboratory equipment and instrumentation;
technical and scientific consulting and management for
companies in the life sciences fields pertaining to digital
compression of computer data; technical and scientific
consulting and management for companies in the life sciences
fields pertaining to GxP (Good Practice) cloud seeding
services; 5) 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; 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; 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; 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)
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; 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; provision of information online pertaining
to regulatory compliance in the fields of medical devices,
medical technologies, medications, biopharmaceuticals,
biotechnology and regulatory compliance consulting in the
fields of biologics, pharmaceuticals, prescription drugs and
medical devices