BROCHURE

Developing a CMC andregulatory roadmap
for your molecule

APIBIOLOGICSVIRAL VECTORSERVICESEARLY AND LATEPHASE DEVELOPMENT

CLINICAL TRIAL

LOGISTICS

COMMERCIAL

SOLUTIONSSERVICES

MANUFACTURING

1Gain access to CMC and regulatory services from drug
development through to commercialization
Navigating a complex regulatory environment is vital to thesuccess of your molecule’s lifecycle. Thermo Fisher Scientific
has managed regulatory submissions in over 180 countries.
We provide a range of flexible regulatory solutions that canhelp easily address your molecule’s unique needs andchallenges, while being backed by a global network andseasoned regulatory experts.

Thermo Fisher Scientific has an integrated global network ofsites comprising regulatory, technical, quality, QP (EU buyer),and customer engagement teams—each team can help
support and solve complex challenges through every step ofyour molecule’s lifecycle. Our regulatory solutions for oral
solid dose and steriles span across our global network.

22

TABLE OF CONTENTS
4

Regional support and expertise5

CMC strategy development

6

Business continuity and supply chain

7

Global and regional launches

8Integrated regulatory solution
Document preparation
Document review
Regulatory expertise3Our regional support and expertise from 2020-2023
We provided regulatory services on 477 dossiers (writing and review), related to 185 products.

46%

EUROPEAN UNION/UK

40%
UNITED STATES

14%REST OF WORLD

4

CMC strategy development
Avoid rework and costly delays by getting your regulatory
strategy right from the start
In a recent study amongst new and emerging and large
pharma, leveraging a CDMO with regulatory experience
was an important attribute. We understand that getting
your CMC strategy right from the start of your molecule’s
journey can help save time and money as you advancethrough each phase and proceed to commercialization.
Our regulatory experts will help you:
• Build a robust and flexible regulatory strategy forthe short-term and long-term• Outline your options, so you can make the best
decision for your project• Understand and evaluate trade-offs to ensure theyalign with your goals and strategy• Plan best practices for your product’s lifecycle• Optimize your submission to help you get to thenext phase with efficiency

Supporting you every step of the way

PHASE III

POST-APPROVAL/
LIFECYCLE
MANAGEMENTPHASE I
PHASE II

MARKETING
APPROVAL

5Business continuity and supply chain
Address your regulatory needs and challenges withproactive planning and problem solving
Proactive planning is critical for setting your short-term andlong-term strategy and prioritization. To drive efficiencies,
here are some key considerations we can work with you on:• Planning: Establish a realistic timeline that fits into
the scope and vision of your project. If you plan
your program early on, you’ll know what data youneed to be collecting without putting your next
target submission at risk of delays.
• Supply chain: The movement of product is critical to
the success of your project. It’s important to beprepared for the import/export of your drug product.
Prioritize initiatives and enhance strategic decision
making by conducting a gap assessment
Trying to navigate the regulatory process of drug
development can be complex and challenging. It’s common
to focus on the high-level, current tasks at hand, without
thinking more holistically about the regulatory process andyour molecule’s lifecycle. With a high-level approach,
important steps and milestones are often missed, which cancause lengthy timelines or add additional costs to yourproject. Our regulatory experts will help with acomprehensive, phase-appropriate gap assessment of yourdata to the most current regulatory standards to identify
those milestones.

PRO TIPWe often see delays because of reactive planning vs.
proactive planning, which can also increase costs. For
example, not anticipating site license changes andvalid GMP certificates in some jurisdictions or EU QP
dispositions for product release to the market may
substantially impact timelines.

PRO TIPMore data can enhance strategic decisions and yoursubmissions. However, it takes time to generate data.
Therefore, it’s important to strike the right balance between
generating additional data to better understand/control themanufacturing process, while not unnecessarily delaying
your project from getting to clinic or commercialization. In
addition to this, there are innovative approaches such as
QbD (Quality by Design) and continuous manufacturing
to help strengthen your process.

Data: Access to the right type, quantity, and forms of data
can help enable strategic decisions and ensure you havethe data that is necessary for your submissions. Our experts
will help guide you on:• Data requirements at each stage of thedevelopment process for your global submissions• What tests to include in the regulatory
specifications• How to best justify your specification• When method validation should be completed• What compatibility studies are required with yourcontainer closure, device, and for dilution ofreconstituted product• What stability data is needed at what stageof development• How much stability is needed under what
conditions• How many pilot/commercial scale batches• Specific requirements to be considered for certain
dosage forms/product types• What process validation data needs tobe submitted

6

Global and regional launches
Holistically planning about your global and regional launches
Even if right now you are only considering a regional - or country-specific launch, it’s important to look at it from a global
perspective. Evaluating your strategy at a global scale can help save rework, unexpected barriers, and costs.

PRO TIPEven if you are years away from thinking about global markets, building it into your regulatory strategy from the start canenable you to proactively make strategic decisions. Here are some common challenges we often see:
• Specifications: In many circumstances, teams are only focused on the first country/market’s specifications. Later,when people start thinking about global scale, they can discover that those specifications might not be suited for thenext market.
• Processes: Sometimes the process you use to sample a product in testing can have different requirements fromcountry to country. When customers don’t account for this, there is a lot of rework that needs to be done.
Please note that you don’t have to have every piece of information and detail figured out for these future markets;
however, taking some time to think globally and holistically can save you time, money, and resources.

“The team has always been willing to extend itself to meet our timelines and provide
for the patient.”— Midsize drug development company, USA“Great communication and document turnaround.”— Large pharma company, USA7

Integrated regulatory solution
Shorten timelines with fewer intermediaries
Moving through each phase with speed and agility is criticalto the success of your small or large molecule. Our regulatory
experts are here to connect and support every step of yourproject and network. Leverage our integrated regulatory
solutions to:• Access a range of CMC regulatory services for all
product types manufactured across sites.
• Support ICH Common Technical Document (CTD)
Quality/Module 3 for clinical and commercial
applications and lifecycle maintenance.
• Support multi-jurisdictions such as USA, EU, andCanada, as well as international/Rest-of-World(RoW) registrations.
• Provide deliverables that are in alignment withthe latest regulatory standards.

Document preparation1
ACTIVITIESDESCRIPTIONS

Complete CMC
dossier sections[Module 3.2.S,3.2.P, 3.2.A 3.2.R]•Preparation of complete or partial, publishing-ready, Drug Substance (DS), Drug Product (DP)and/or Appendices modules, including authoring, review rounds (internal and costumer), andcomments integration•Authoring and review of responses to agency questions

Clinical trial applications (CTA Phase 1, 2, and 3):•••

USA Investigational New Drug Application (IND)
EU Investigational Medical Product Dossier (IMPD)
Related amendments

Marketing application:

ICH regions2••••

USA New Drug Application (NDA)
USA Biological License Application (BLA)
USA Abbreviated New Drug Application (ANDA)
EU Marketing Authorization Application (MAA)

Post-approval changes:
••
•
•
•
•
Non-lCH regions
1
2

USA Prior Approval Supplement (PAS)
USA Change Being Effective (CBE)/(CBE30)
USA Annual Report (AR)EU Type II variation
EU Type IB variation
EU Type IA variation

Authoring, editing, and assessment of dossiers case-by-case

In English, with the possibility of technical report translation
End-to-end dossier preparation of all modules available on request

8Document review
ACTIVITIESCMC dossier review

DESCRIPTIONS•Assessment of customer’s submission drafts for consistency with current
Thermo Fisher Scientific site practices and regulatory standards•

Gap analysis summary report of current dossiers, in support of technology transfersand product inspection preparedness, per CTD granularity

Regulatory expertise
ACTIVITIES
Project regulatory liaison

Regulatory consulting
and strategy

DESCRIPTIONSParticipation in customer’s routine project team and/or milestone meetings
Provision of ad hoc regulatory consulting and strategies across product life-cycle per
customer request
Assistance in regulatory agencies meetings (e.g. requests, briefing books, minutes)

Regulatory training/
workshopPreparation and delivery of customer-specific training on applicable regulatory topics,frameworks, procedures, GMP, and trends

At Thermo Fisher Scientific, our regulatory experts will do more than write the narrative for your approval. We will work handin-hand with you to build a robust and flexible regulatory strategy and proactively address problems.

Need help filing your submission and developing your regulatory strategy?
Contact us now.

9+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com
Published 07/24 © 2024 Thermo Fisher Scientific Inc. All rights reserved.