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Sources of advantage
in Regulatory Filing
Management
November 2021
By Daniel Kaegi, Myrto Lee, Shana Topp, Clemens Möller, and Philipp Pauli
Boston Consulting Group partners with leaders
in business and society to tackle their most
important challenges and capture their greatest
opportunities. BCG was the pioneer in business
strategy when it was founded in 1963. Today,
we work closely with clients to embrace a
transformational approach aimed at benefiting all
stakeholders—empowering organizations to grow,
build sustainable competitive advantage, and
drive positive societal impact.
Our diverse, global teams bring deep industry and
functional expertise and a range of perspectives
that question the status quo and spark change.
BCG delivers solutions through leading-edge
management consulting, technology and design,
and corporate and digital ventures. We work in a
uniquely collaborative model across the firm and
throughout all levels of the client organization,
fueled by the goal of helping our clients thrive and
enabling them to make the world a better place.
BOSTON CONSULTING GROUP 1
Sources of advantage in Regulatory
Filing Management
Navigating the regulatory landscape has never been more
challenging. Innovation is at an all-time high, with many
novel platforms and products being launched and a grow-
ing prevalence of devices and combination products. At the
same time, biopharmaceutical companies continue to
serve an increasing number of countries, including emerg-
ing markets, where some health authorities are still in the
process of building out their capabilities.
Meanwhile, regulatory requirements and their scope are
changing quickly. Increasingly, they pertain to areas beyond
the actual dossier content, such as tracing and anticoun-
terfeiting, adding work for regulatory departments. What’s
more, new technologies (for example, biologics and cell-
and gene-therapies) and concepts (Quality by Design and
the definition of Established Conditions with ICH Q12)
create additional layers of complexity to the production
and submission of these critical data packages.
In this environment, pharma companies need to manage
many important yet highly complex processes across many
internal functions, external stakeholders, and countries.
Digital advances, alongside capabilities provided by the
Regulatory Information System (RIS), offer a means to
more effectively navigate this complexity and put the next
level of efficiency within reach. Companies are now focused
on bringing these digital solutions and systems to scale to
drive more effective process management in the regulatory
space.
Although there are many opportunities to optimize pro-
cesses, the following discussion will focus on two topics of
high priority and impact: 1) the customizing of dossier
content to meet local regulatory requirements, and 2) the
timing related to the submission of these dossiers to local
health authorities. (See Exhibit 1.)
When submitting an updated dossier to a local health
authority (HA), many companies have insufficient visibility
into the current status of the submission, a history of the
changes made along the way, and the latest updates on
the dossiers/timelines as they are made. This lack of clari-
ty tends to compound through the lifecycle of a product.
A responsive and dynamic approach that tracks and man-
ages this information and gives everyone along the value
chain visibility is the basis for a more efficient and effective
management of dossier changes and submission timelines.
In this paper, we don’t describe specificially how to imple-
ment these changes, since adjustments will vary with the
company. Rather, we focus on explaining what better visi-
bility of this information can achieve. Companies can then
tailor their approach to the needs of their regulatory eco-
system.
Exhibit 1 - Process for submitting an updated dossier to local health
authority (HA)
Source: BCG Analysis
Headquarters
Affiliate
Prepare global
dossiers
Dispatch to
Affiliate
Implementation
planning
Submission
generation
Submission
preparation
HA review Inform HQ
Set regulatory
Implementation
strategy
Provide content
 timeline
feedback
Customize local
dossier
Submit to HA Report HA feed
back and QA
2 SOURCES OF ADVANTAGE IN REGULATORY FILING MANAGEMENT
Strengthening the Visibility and Control
of Dossier Content
Of the five modules that companies must prepare when
registering updated pharmaceutical products, the one
where changes are made most frequently is Module 3. This
module covers the pharmaceutical formulation, manufac-
turing process and the different sites for each step, analyti-
cal methods, container closure system, and stability data.
Capturing Changes More Easily
Legacy approaches for capturing content changes within
these modules are typically inefficient. Companies often
make one-to-one comparisons between pre-existing and
new dossier versions - a manual process that is lengthy
and error prone. Complicating matters further, there can
be many documents for different products and markets,
with each document evolving over time.
Explicitly capturing what was changed in a specific dossier
(such as adding another piece of information on cell cul-
ture in a specific section or structuring information differ-
ently because of a local country requirement) and catego-
rizing these changes (such as rephrasing a paragraph,
adding more details, or removing some) made to a specific
dossier section will highlight what is of greatest interest.
This practice would require every author conducting a
change to explicitly indicate whether information has been
added, removed, or rephrased and provide a brief descrip-
tion of the change. (See Exhibit 2.).
Better Visibility, Better Decisions
This approach has important advantages. It captures
changes made at any point and creates an unambiguous
view on current status and contributions to a dossier status
over time.
Moreover, it allows analysis about dossier content changes
across products and filings over time to identify patterns
for specific countries or product platforms (for example,
the degree of local adaptation or the level of detail provid-
ed for a specific manufacturing procedure). By comparing
these, the analytics can, for example, provide a better
understanding of how much local customization a particu-
lar submission requires.
Synchronizing Submission and Approval
Timelines
In addition to managing changes to dossier content, phar-
maceutical companies must also coordinate submission
and approval timelines. This is an equally challenging task
given the internal and external factors that will impact
initially defined filing timelines.
Often it is difficult for all involved parties to get a real-time,
accurate view on an expected milestone that takes the
latest delays or advancements into account.
Exhibit 2 - A simpler Way to Track dossier Content Change (illustrative
example)
Source: BCG Analysis
Date 29-Feb-21 Country Brazil
Product Indromentila Submission Nb 007
Owner Crista Merro Subm.type B
Phase Local customization pre-submission
Rationale
for change
Needed to adapt submission for Brazil specific requirements
Impact Drug Substance Drug Product
Criticality Low Medium High
Status Draft Awaits HQ review HQ Go ahead
View by section:
Section Change type Description
Rephrase
3.2.S.2
3.2.S.1
More details Added info on cell culture harvest as required by Brazil HA
3.2.P.4 Less content We don't need container closure system information
Country-specific version needed: Brazil does not follow the
same structure, need to present information differently
Submission generation Submission preparation
Customization
Pre-
customization
Preparation of
global dossier
QA
Potential
modification
HA review Inform HQ
Implementation
planning
Global
dossier
Author indicating
specific change
Regional/cluster
version
Local version
before submission
Local version after
submission
Local approved
version
Submission Approval
Dispatch
BOSTON CONSULTING GROUP 3
Regulatory functions typically capture three milestones
and align them across the enterprise: 1) the dispatch of
submissions to the affiliates; 2) the submission of the
updated dossier by each affiliate to the particular country’s
health authorities for approval; and 3) the approval of the
dossier by the health authorities. (See Exhibit 2.)
For each of these milestones we often see companies
asking for two types of dates: 1) the date that headquarters
commits to, based on the overall plan and specific lead
times provided by the affiliate; and 2) the date provided by
the affiliate, which can be the same date as proposed by
headquarters, or an alternative.
“Current View” Often Missing
This approach, however, does not provide a “current view”
on the latest dates expected based on progress made and
best actual knowledge of all involved. As a result, much
back-and-forth outside the regular flow of communication
is needed to stay on top on the latest expected dates.
We recommend adding a third date—the affiliate’s “cur-
rent view” of the latest expected date for each milestone
laid out above, along with a brief explanation of why any
deviations (if applicable) have ocurred. (See Exhibit 3.) This
allows country offices to stay abreast of any date changes
and understand the underlying rationale so that they can
take better proactive measures where needed.
Proactively Managing What Lies Ahead
The addition of a “current view” benefits all involved, as
changes and delays are made visible early in the process.
With this information at their fingertips, companies can
proactively manage delays (for instance, anticipate early a
potential delay in submission caused by a crunch in local
DRA resources), mitigate on the individual filing level (for
example, by complementing additional resources needed),
and look for patterns on the regional or product level
(which could encompass both potential delays or patterns
in adaptation).
The timing has never been better to bring a step-change
to the regulatory filing process.
As innovation cycles accelerate, product platforms multiply,
and regulatory complexity grows, boosting the digital matu-
rity of regulatory functions and RIS capabilities will be
critical for coping with what we expect will be an exponen-
tial increase in both volume (as in number of filings) and
complexity (as in the multitude of countries and produc-
tion platforms covered).
To get the most benefit, companies need to start systemat-
ically optimizing regulatory processes now. A thorough
assessment of the starting point, followed by diligent prior-
itization and logical sequencing of changes to be made.
This approach will be essential for realizing the step-
change pharma companies so greatly need.
Exhibit 3 - Tracking the dates of the submission timeline
Source: BCG Analysis
Headquarters
Affiliate
Dispatch Submission
HQ plan HQ plan
Approval
Submission Approval
Originally
committed
Affiliate
view
Affiliate
view
Current view
on expected
Current view
on expected
Current view
on expected
HQ entering dates based on overall
planand Affiliate Specific lead times
Affiliate confirms or provides
alternative date
Date owner provides regular
updates on based current view
Flag raised if current view is
outside of pre-defined
tolerance range
4 SOURCES OF ADVANTAGE IN REGULATORY FILING MANAGEMENT
About the Authors
Daniel Kaegi is a Managing Director and Partner in the
Zurich office of Boston Consulting Group.
Kaegi.Daniel@bcg.com
Shana Topp is a Managing Director and Partner in BCG’s
Boston office.
Topp.Shana@bcg.com
Philipp Pauli is a Principal, located in BCG’s Zurich office.
Pauli.Philipp@bcg.com
Myrto Lee is a Managing Director and Partner in the
firm’s London office.
Lee.Myrto@bcg.com
Clemens Möller is a Managing Director and Partner in
BCG’s Boston office.
Moeller.Clemens@bcg.com
For Further Contact
If you would like to discuss this report, please contact the
authors.
Boston Consulting Group partners with leaders
in business and society to tackle their most
important challenges and capture their greatest
opportunities. BCG was the pioneer in business
strategy when it was founded in 1963. Today, we
help clients with total transformation—inspiring
complex change, enabling organizations to grow,
building competitive advantage, and driving
bottom-line impact.
To succeed, organizations must blend digital and
human capabilities. Our diverse, global teams
bring deep industry and functional expertise
and a range of perspectives to spark change.
BCG delivers solutions through leading-edge
management consulting along with technology
and design, corporate and digital ventures—
and business purpose. We work in a uniquely
collaborative model across the firm and
throughout all levels of the client organization,
generating results that allow our clients to thrive.
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autet hario qui a nust faciis reperro vitatia
dipsandelia sit laborum, quassitio. Itas volutem
es nulles ut faccus perchiliati doluptatur. Estiunt.
Et eium inum et dolum et et eos ex eum harchic
teceserrum natem in ra nis quia disimi, omnia
veror molorer ionsed quia ese veliquiatius
sundae poreium et et illesci atibeatur aut que
consequia autas sum fugit qui aut excepudit,
omnia voloratur? Explige ndeliaectur magnam,
que expedignist ex et voluptaquam, offici bernam
atqui dem vel ius nus.
Nem faccaborest hillamendia doluptae
conseruptate inim volesequid molum quam,
conseque consedipit hillabo. Imaio evelenditium
haribus, con reictur autemost, vendam am ellania
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Sources of advantage in Regulatory Filing Management

  • 1. White Paper Sources of advantage in Regulatory Filing Management November 2021 By Daniel Kaegi, Myrto Lee, Shana Topp, Clemens Möller, and Philipp Pauli
  • 2. Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders—empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place.
  • 3. BOSTON CONSULTING GROUP 1 Sources of advantage in Regulatory Filing Management Navigating the regulatory landscape has never been more challenging. Innovation is at an all-time high, with many novel platforms and products being launched and a grow- ing prevalence of devices and combination products. At the same time, biopharmaceutical companies continue to serve an increasing number of countries, including emerg- ing markets, where some health authorities are still in the process of building out their capabilities. Meanwhile, regulatory requirements and their scope are changing quickly. Increasingly, they pertain to areas beyond the actual dossier content, such as tracing and anticoun- terfeiting, adding work for regulatory departments. What’s more, new technologies (for example, biologics and cell- and gene-therapies) and concepts (Quality by Design and the definition of Established Conditions with ICH Q12) create additional layers of complexity to the production and submission of these critical data packages. In this environment, pharma companies need to manage many important yet highly complex processes across many internal functions, external stakeholders, and countries. Digital advances, alongside capabilities provided by the Regulatory Information System (RIS), offer a means to more effectively navigate this complexity and put the next level of efficiency within reach. Companies are now focused on bringing these digital solutions and systems to scale to drive more effective process management in the regulatory space. Although there are many opportunities to optimize pro- cesses, the following discussion will focus on two topics of high priority and impact: 1) the customizing of dossier content to meet local regulatory requirements, and 2) the timing related to the submission of these dossiers to local health authorities. (See Exhibit 1.) When submitting an updated dossier to a local health authority (HA), many companies have insufficient visibility into the current status of the submission, a history of the changes made along the way, and the latest updates on the dossiers/timelines as they are made. This lack of clari- ty tends to compound through the lifecycle of a product. A responsive and dynamic approach that tracks and man- ages this information and gives everyone along the value chain visibility is the basis for a more efficient and effective management of dossier changes and submission timelines. In this paper, we don’t describe specificially how to imple- ment these changes, since adjustments will vary with the company. Rather, we focus on explaining what better visi- bility of this information can achieve. Companies can then tailor their approach to the needs of their regulatory eco- system. Exhibit 1 - Process for submitting an updated dossier to local health authority (HA) Source: BCG Analysis Headquarters Affiliate Prepare global dossiers Dispatch to Affiliate Implementation planning Submission generation Submission preparation HA review Inform HQ Set regulatory Implementation strategy Provide content timeline feedback Customize local dossier Submit to HA Report HA feed back and QA
  • 4. 2 SOURCES OF ADVANTAGE IN REGULATORY FILING MANAGEMENT Strengthening the Visibility and Control of Dossier Content Of the five modules that companies must prepare when registering updated pharmaceutical products, the one where changes are made most frequently is Module 3. This module covers the pharmaceutical formulation, manufac- turing process and the different sites for each step, analyti- cal methods, container closure system, and stability data. Capturing Changes More Easily Legacy approaches for capturing content changes within these modules are typically inefficient. Companies often make one-to-one comparisons between pre-existing and new dossier versions - a manual process that is lengthy and error prone. Complicating matters further, there can be many documents for different products and markets, with each document evolving over time. Explicitly capturing what was changed in a specific dossier (such as adding another piece of information on cell cul- ture in a specific section or structuring information differ- ently because of a local country requirement) and catego- rizing these changes (such as rephrasing a paragraph, adding more details, or removing some) made to a specific dossier section will highlight what is of greatest interest. This practice would require every author conducting a change to explicitly indicate whether information has been added, removed, or rephrased and provide a brief descrip- tion of the change. (See Exhibit 2.). Better Visibility, Better Decisions This approach has important advantages. It captures changes made at any point and creates an unambiguous view on current status and contributions to a dossier status over time. Moreover, it allows analysis about dossier content changes across products and filings over time to identify patterns for specific countries or product platforms (for example, the degree of local adaptation or the level of detail provid- ed for a specific manufacturing procedure). By comparing these, the analytics can, for example, provide a better understanding of how much local customization a particu- lar submission requires. Synchronizing Submission and Approval Timelines In addition to managing changes to dossier content, phar- maceutical companies must also coordinate submission and approval timelines. This is an equally challenging task given the internal and external factors that will impact initially defined filing timelines. Often it is difficult for all involved parties to get a real-time, accurate view on an expected milestone that takes the latest delays or advancements into account. Exhibit 2 - A simpler Way to Track dossier Content Change (illustrative example) Source: BCG Analysis Date 29-Feb-21 Country Brazil Product Indromentila Submission Nb 007 Owner Crista Merro Subm.type B Phase Local customization pre-submission Rationale for change Needed to adapt submission for Brazil specific requirements Impact Drug Substance Drug Product Criticality Low Medium High Status Draft Awaits HQ review HQ Go ahead View by section: Section Change type Description Rephrase 3.2.S.2 3.2.S.1 More details Added info on cell culture harvest as required by Brazil HA 3.2.P.4 Less content We don't need container closure system information Country-specific version needed: Brazil does not follow the same structure, need to present information differently Submission generation Submission preparation Customization Pre- customization Preparation of global dossier QA Potential modification HA review Inform HQ Implementation planning Global dossier Author indicating specific change Regional/cluster version Local version before submission Local version after submission Local approved version Submission Approval Dispatch
  • 5. BOSTON CONSULTING GROUP 3 Regulatory functions typically capture three milestones and align them across the enterprise: 1) the dispatch of submissions to the affiliates; 2) the submission of the updated dossier by each affiliate to the particular country’s health authorities for approval; and 3) the approval of the dossier by the health authorities. (See Exhibit 2.) For each of these milestones we often see companies asking for two types of dates: 1) the date that headquarters commits to, based on the overall plan and specific lead times provided by the affiliate; and 2) the date provided by the affiliate, which can be the same date as proposed by headquarters, or an alternative. “Current View” Often Missing This approach, however, does not provide a “current view” on the latest dates expected based on progress made and best actual knowledge of all involved. As a result, much back-and-forth outside the regular flow of communication is needed to stay on top on the latest expected dates. We recommend adding a third date—the affiliate’s “cur- rent view” of the latest expected date for each milestone laid out above, along with a brief explanation of why any deviations (if applicable) have ocurred. (See Exhibit 3.) This allows country offices to stay abreast of any date changes and understand the underlying rationale so that they can take better proactive measures where needed. Proactively Managing What Lies Ahead The addition of a “current view” benefits all involved, as changes and delays are made visible early in the process. With this information at their fingertips, companies can proactively manage delays (for instance, anticipate early a potential delay in submission caused by a crunch in local DRA resources), mitigate on the individual filing level (for example, by complementing additional resources needed), and look for patterns on the regional or product level (which could encompass both potential delays or patterns in adaptation). The timing has never been better to bring a step-change to the regulatory filing process. As innovation cycles accelerate, product platforms multiply, and regulatory complexity grows, boosting the digital matu- rity of regulatory functions and RIS capabilities will be critical for coping with what we expect will be an exponen- tial increase in both volume (as in number of filings) and complexity (as in the multitude of countries and produc- tion platforms covered). To get the most benefit, companies need to start systemat- ically optimizing regulatory processes now. A thorough assessment of the starting point, followed by diligent prior- itization and logical sequencing of changes to be made. This approach will be essential for realizing the step- change pharma companies so greatly need. Exhibit 3 - Tracking the dates of the submission timeline Source: BCG Analysis Headquarters Affiliate Dispatch Submission HQ plan HQ plan Approval Submission Approval Originally committed Affiliate view Affiliate view Current view on expected Current view on expected Current view on expected HQ entering dates based on overall planand Affiliate Specific lead times Affiliate confirms or provides alternative date Date owner provides regular updates on based current view Flag raised if current view is outside of pre-defined tolerance range
  • 6. 4 SOURCES OF ADVANTAGE IN REGULATORY FILING MANAGEMENT About the Authors Daniel Kaegi is a Managing Director and Partner in the Zurich office of Boston Consulting Group. Kaegi.Daniel@bcg.com Shana Topp is a Managing Director and Partner in BCG’s Boston office. Topp.Shana@bcg.com Philipp Pauli is a Principal, located in BCG’s Zurich office. Pauli.Philipp@bcg.com Myrto Lee is a Managing Director and Partner in the firm’s London office. Lee.Myrto@bcg.com Clemens Möller is a Managing Director and Partner in BCG’s Boston office. Moeller.Clemens@bcg.com For Further Contact If you would like to discuss this report, please contact the authors.
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