Chapter 4: Components of Regulatory Strategy – The Basics
48 Regulatory Affairs Professionals Society
data needed. If the plan features an expectation for
the result, it should be listed in the table as well, as
it could be the hypothesis for a quantitative research
activity. Because this list frequently needs adjustment
as the research process moves forward, it should be
readily available and edited accordingly.
A simplified example is shown in Table 4-1. It
is very tempting to jump into a previously assembled
strategy and follow its pathway. Time is precious,
and every minute that can be saved is a valuable
commodity. However, it is important to remember
that the path previously followed may not lead to the
same conclusion. The regulatory environment is fluid.
Requirements can change quickly. These questions
should be asked before proceeding to document the
strategy:
• Is the clinical application understood?
• Are the business and market objectives
understood?
• Are the technology and engineering aspects
understood?
• Is the competitive landscape understood?
• Is the regulatory and compliance history of exist-
ing products understood, in all desired national
markets?
• Are the clinical evidence or clinical trial require-
ments understood?
• Are there regulatory or clinical practice trends
that will affect the product?
If the answer to any of these questions is “no,”
the team should take the time to conduct further
research. With the advent of the internet and genera-
tive AI tools, online searches for product information
can lead to many sources. Even with almost too much
information to sift through, it is worth the effort. The
regulatory professional should compile notes on var-
ious research areas. Although not everything found
during research may go into the regulatory strategy
document, it can be very valuable for future research
efforts.
This task may appear to require a great deal of
research to perform before even starting to assemble
the GRS and may take more time than preferred, but
it will provide long-term benefits. The more thorough
the research, the better the GRS and regulatory plan
will be, reducing the number and impact of surprises
that often show up over the course of a project.
Product Plan
Questions to answer:
• What device(s) is/are the subject of the plan?
• What countries have been targeted in the prod-
uct plan?
• What is the desired timeframe for each proposed
market introduction?
• Is the device new to the company, or is it an
improvement/iteration of an existing device?
• What are the key assumptions in the company’s
product plan?
• What are the key regulatory risks (and associated
schedule risks) in the plan?
• What is the plan to collect supporting data?
To create a regulatory strategy, the regulatory profes-
sional first must understand the product, its clinical
use, and the countries included in the company’s
plan. Every segment of an organization desires to
be in every available market as quickly as possible.
However, the reality is each country will have its own
requirements and timing. The costs of obtaining and
maintaining a marketing authorization may mean
entry into every targeted country may not be reason-
able, based on the product’s sales potential. Absent
Table 4-1. GRS Simplified Element Table
GRS Element Project Expectation Research
Methodology
Data Needed
Review time (each
target market)
90-180 days Quantitative &
Qualitative
• Published review times (as available)
• Previous experience
• Regulatory network resources
Available guidance/
standards
Yes Qualitative • International standards list
• Standards used in previous submissions
• Accepted standards declarations (country-specific)
Clinical study needs None for premarket Qualitative • Guidance documents
• Previous submissions for competitive products
Environmental
trends
None Qualitative • Review of public meeting schedules (past and present)
• Guidance documents (planned or pending)
• Public health issues
• Legislative activity
48 Regulatory Affairs Professionals Society
data needed. If the plan features an expectation for
the result, it should be listed in the table as well, as
it could be the hypothesis for a quantitative research
activity. Because this list frequently needs adjustment
as the research process moves forward, it should be
readily available and edited accordingly.
A simplified example is shown in Table 4-1. It
is very tempting to jump into a previously assembled
strategy and follow its pathway. Time is precious,
and every minute that can be saved is a valuable
commodity. However, it is important to remember
that the path previously followed may not lead to the
same conclusion. The regulatory environment is fluid.
Requirements can change quickly. These questions
should be asked before proceeding to document the
strategy:
• Is the clinical application understood?
• Are the business and market objectives
understood?
• Are the technology and engineering aspects
understood?
• Is the competitive landscape understood?
• Is the regulatory and compliance history of exist-
ing products understood, in all desired national
markets?
• Are the clinical evidence or clinical trial require-
ments understood?
• Are there regulatory or clinical practice trends
that will affect the product?
If the answer to any of these questions is “no,”
the team should take the time to conduct further
research. With the advent of the internet and genera-
tive AI tools, online searches for product information
can lead to many sources. Even with almost too much
information to sift through, it is worth the effort. The
regulatory professional should compile notes on var-
ious research areas. Although not everything found
during research may go into the regulatory strategy
document, it can be very valuable for future research
efforts.
This task may appear to require a great deal of
research to perform before even starting to assemble
the GRS and may take more time than preferred, but
it will provide long-term benefits. The more thorough
the research, the better the GRS and regulatory plan
will be, reducing the number and impact of surprises
that often show up over the course of a project.
Product Plan
Questions to answer:
• What device(s) is/are the subject of the plan?
• What countries have been targeted in the prod-
uct plan?
• What is the desired timeframe for each proposed
market introduction?
• Is the device new to the company, or is it an
improvement/iteration of an existing device?
• What are the key assumptions in the company’s
product plan?
• What are the key regulatory risks (and associated
schedule risks) in the plan?
• What is the plan to collect supporting data?
To create a regulatory strategy, the regulatory profes-
sional first must understand the product, its clinical
use, and the countries included in the company’s
plan. Every segment of an organization desires to
be in every available market as quickly as possible.
However, the reality is each country will have its own
requirements and timing. The costs of obtaining and
maintaining a marketing authorization may mean
entry into every targeted country may not be reason-
able, based on the product’s sales potential. Absent
Table 4-1. GRS Simplified Element Table
GRS Element Project Expectation Research
Methodology
Data Needed
Review time (each
target market)
90-180 days Quantitative &
Qualitative
• Published review times (as available)
• Previous experience
• Regulatory network resources
Available guidance/
standards
Yes Qualitative • International standards list
• Standards used in previous submissions
• Accepted standards declarations (country-specific)
Clinical study needs None for premarket Qualitative • Guidance documents
• Previous submissions for competitive products
Environmental
trends
None Qualitative • Review of public meeting schedules (past and present)
• Guidance documents (planned or pending)
• Public health issues
• Legislative activity