Copyright © 2021 pepgra. All rights reserved 1

Top Tips for a Medical Writer to Prepare a Successful NDA

Dr. Nancy Agnes, Head,

Technical Operations, Pepgra

Sales.cro@pepgra.com

In-Brief

Medical writers must be subject matter

experts of the regulatory control inside and

out and know the drug under study in

clinical research. To prepare a successful

NDA(New drug application), a medical

writer should know all the regulatory

submissions basics. Pepgra provides you

with essential tips for a medical writer to

prepare a successful NDA and provides

regulatory writing services.

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I. INTRODUCTION

Medical writing includes writing scientific

documents of different types, with

regulatory and research-related papers,

disease or drug-related and promotional

literature, publication articles like journals,

manuscripts and abstracts, essential content

for healthcare sites, health-related

publications or news articles. The scientific

data in these documents need to be

accessible to suit the target audience's level

of understanding, namely, patients or the

general public, physicians or the regulators.

Medical writers require an understanding of

the medical concepts and terminology,

knowledge of relevant guidelines regarding

the structure and contents of authentic

documents, and good writing skills. They

also need to be familiar with searching

medical literature, understanding and

presenting research data, document

reviewing, and editing and publishing

requirements. Many resources are now

accessible for medical writers to regularly

get vital training in medical writing science

and art and regularly upgrade their

knowledge and skills. The demand for the

medical report is growing gradually in

pharmaceutical and healthcare

communication marketplace. Medical

writers can work individually or active as

full-time professionals.

Copyright © 2021 pepgra. All rights reserved 2

II. TIPS FOR A MEDICAL WRITER TO

PREPARE A SUCCESSFUL NDA

It's never too early to start your NDA

preparation.

It would help if you began to think about

your eventual NDA( New Drug Application)

from the moment you start planning for your

Pre-IND meeting and IND submission, and

well before you have dosed a single patient.

For instance:

What is the most suitable regulatory

path?

What are clinical trials needed for

the NDA and product label to be

supported?

Do you plan to seek expedited

growth and expedited review?

What is production information

needed for the NDA?

To help your application, do you

need long-term

toxicology/carcinogenicity studies?

What needs to be outsourced?

All these questions should be front and

centre as early as possible in your mind.

Even though your NDA submission seems

far off shortly, early preparation will make

the difference between smooth sailing and

rough seas.

Start assembling your NDA

Far too often, sponsors wait to start

compiling their NDA until late in

production, which can place undue pressure

on resources and timelines. Note, each piece

of the NDA you can finish and "put on the

shelf" is one bit less that you have to think

about later. You can relax a little better as

the submission date approaches by knowing

what elements can be accomplished early

and then proactively completing those

assignments during medical writing in

clinical trials.

In most cases, by the time the drug reaches

the clinic, a significant portion of the

nonclinical program will be completed. All

of this information can be explicitly pulled

into the NDA's related modules and

incorporated as other studies become final.

On the clinical side, as soon as you can, you

should start reviewing your data and

preparing your clinical research reports

(CSRs). Before the research is complete,

you can even start on the report shell. You

can then collect the rest of the components

and collect all the required approval

Copyright © 2021 pepgra. All rights reserved 2

signatures until final data is available.

Analyses have been carried out using

regulatory medical writing in clinical trials.

When the time comes to colonize the NDA

clinical overview pages, completing these

activities would also encourage

performance.

Know the related laws and regulatory

guidelines

The FDA review division must manage your

application, and for NDAs in general, to

understand the applicable laws and

regulatory guidelines that relate to your

specific program. Although rules are legally

binding, documents of advice are not in

regulatory writing. However, guidance

documents include the regulators' latest

thinking, reviewing the NDA (and hopefully

approve it). Therefore, it should be done

with caution, reason, and consultation with

the FDA's relevant review division to

deviate from these guidelines.

Use standardized templates

When you start writing your IND, make sure

you use uniform models and that a standard

style guide regulates all authorship. To put

together a masterful submission, you don't

have to have a fancy eCTD template kit, but

you can make sure your submission

documents conform to a standard format and

style wherever possible. The same

grammatical, punctuation, numbering,

abbreviation, and text conventions should be

practical by all writers working on the

submission and should understand how to

preserve the dignity of the underlying

document's formatting and styles.

Because of all the data and scientific weight

in the submission, this may seem like a

minor detail. Still, a polished, well-written,

regularly formatted application package that

conforms to current regulatory document

requirements goes a long way to the success

of a submission.

Enter your study data

To get all your early-phase data entered,

queried, cleaned, and locked, do not wait

until Phase 3. It will save many headaches,

later on, to get an early start on data

management and free up time to emphasis

on other tasks as the NDA submission date

approaches. If the data is locked, you can

start producing study-specific tables,

listings, and figures to help study reports and

summaries inside the NDA.

Request a Pre-NDA meeting

Your primary late-stage opportunity to get

feedback from the FDA on your request is

the Pre-NDA meeting. As such, you must

put a lot of thought into the topics of

discussion you want to raise and ensure that

the questions you pose are straightforward,

well-supported, and placed to allow the

FDA to make a meaningful response.

Suppose any particular elements of your

program or submission may affect

successful filing or review and have not

been addressed through previous

interactions. In that case, it is now time for

the FDA to discuss them. Prepare your

claims and your "Plan B" well in advance

and consider the possible impacts of both of

these on your submission's content and

deadlines from medical writing solutions.

Copyright © 2021 pepgra. All rights reserved 2

Establish realistic timelines for every

aspect

Communicate deadlines and obligations, and

follow-up often, to all relevant stakeholders

and participants. The overwhelming amount

of information that needs to be obtained,

processed, interpreted, and shared inside the

NDA should be careful in the timelines.

Establishing an NDA "tracker" is one of the

easiest ways to do this. The most important

thing if the tracker is part of a sophisticated

software package specifically designed for

regulatory submissions, a simple

spreadsheet, must contain some crucial and

actionable submission information. It

requires listing constituent documents with

sufficient granularity, the parties involved,

each document's current status, and the due

dates.

Allow at least a month for publishing

your submission

Publishing timelines are often looking at as

something that can be dense if "more

critical" tasks such as authoring or scientific

review take longer than planned. However,

it can sometimes cut to publish timelines,

mainly if study reports and different NDA

parts are being firm up as you go. It is

important not to underrate the vast amount

of effort and time involved in setting up a

proper submission. Even with leading-edge

technologies, publishing needs a

considerable amount of time, not to mention

quality control activities and final validation

of the request, to ensure consistent

document formatting, hyperlinking,

bookmarking, and arrangement within the

eCTD system. Publishing timelines should

be compressed with care, prospectively

wherever possible, and in close contact with

the publishing team at all times.

Take the big picture to guarantee a good

submission

Take a minute to consider the picture of

what it takes to confirm a good proposal,

whether this is your first NDA or just one of

many that you've done. Pulling an NDA

together is a vast undertaking that takes

considerable time and effort to complete an

investment. Consider your organization or

institution's resources and skills and the

internal ability to execute the necessary

tasks in your desired timelines, and then

make a reasonable assessment of whether

additional support is required.

III. CONCLUSION

Pepgra offers several scalable services to

help our clients yield high-quality,

compliant NDA submissions. Suppose you

are thinking of outsourcing your whole

NDA(New Drug Application). In that case,

you need a partner to assist with publishing

and submitting. Even if you have just one or

two papers that may benefit from an

accomplished clinical pharmacology expert's

examination, Pepgra will help regardless of

your need along with Regulatory Writing

Service in Clinical Research.

REFERENCES

1. Lies, R. L. (1984). Preparing the Nda Summary: How

to, How Not to and why. Clinical Research Practices

and Drug Regulatory Affairs, 2(3), 259-271.

2. Schwarz, S. W., Dick, D., VanBrocklin, H. F., &

Hoffman, J. M. (2014). Regulatory requirements for

PET drug production. Journal of Nuclear

Medicine, 55(7), 1132-1137.