There is an agreement among people who worked with a new drug product going through the approval process. The issue is not usually the science. The problem is caused by the dossier. It might take forever to pass validation, there can be a deficiency letter after eight months of the submission, and there is always some labeling issue that could have been solved before submitting. All these factors delay the process and cost a lot of money.

Product approval delay means loss of patent life, gain of competitive advantage by the opponents, and rewriting of financial forecasts. This is exactly the problem that a pharma regulatory consulting company helps to avoid, and a professional company manages to deal with it long before the submission.

Why product approval delays happen

Usually, there are five main issues that cause the product approval delays. The saddest thing is that all of them can be predicted and prevented.

The first issue is poor regulatory planning. Many companies choose a regulatory pathway based on previous experience or familiar processes instead of evaluating the specific requirements of the target market. As development progresses, they often discover that the health authority expects additional data or documentation that was never planned for. 

Second, many delays stem from poor submission quality. Health authorities often raise questions or issue deficiencies because of incomplete dossier sections, inconsistencies between documents, failed eCTD validation, poor translations, or improperly presented stability data. These issues rarely indicate weak science. More often, they are the result of avoidable errors in dossier preparation and assembly. 

Third, it is the response to the health authority questions. When a deficiency letter comes or the agency puts a list of questions, the company should start answering quickly, professionally, and completely. If the company considers the process of interaction with the health authority as something unusual and interruptive, it pays for it in time.

How a regulatory partner changes the situation

It is easy for a regulatory partner to solve these problems in order to avoid any delays.

  • Developing a strategy before submitting

The preparation process starts long before someone prepares the dossier. A good regulatory team should analyze the pathway for each target market, detect the difference in requirements in different agencies, and identify the possible issues the reviewer can put in the review.

This kind of work is called regulatory intelligence and it is rather boring but it is the key to a good development strategy that survives contact with the health authority. For companies that file the product to the markets outside the home market, it is very important.

EU regulations require a Qualified Person who certifies the imported medicinal products, and the US FDA requires a US agent for companies based outside the country. You do not want to learn such information during the submission process. An experienced consulting partner solves all the issues with agency representation and interactions.

  • Creating a submission that passes the review

As the dossier is the place where most of the preventable delays happen, it is the place where a consulting partner invests the majority of its efforts. It means medical writing that presents data properly, publishing and formatting that passes eCTD validation at once, and the review layer that detects contradictions between sections before the agency does.

Sometimes a consultant can perform an agency style review of the submission, reading it the way the FDA or EMA assessor reviews it and putting the objections internally. Such objection solved before filing means that there will be no deficiency letter.

  • Interaction with the health authority

When the submission is filed, it is the turn of responsiveness. Health authority questions are accompanied by deadlines, and the quality of the first response is the determinant of the number of rounds of questions.

The experience of the regulatory partner is useful here: he knows how to prepare the answer properly, how to interpret the data the health authority has already seen and when it is better to make a meeting instead of writing a letter.

Preparation to advisory meeting deserves special attention. Such a meeting managed in a proper way can solve the problem before it becomes a review finding, and if it is managed poorly, it creates additional commitments for the sponsor. Preparation to the interaction is a separate skill and it is one of the best places where the experience can be shown.

  • Preventing approval unraveling afterwards

Product approval is not the end of the story. Labelling changes, variations, renewals, and pharmacovigilance obligations start immediately after the product is on the market, and non-compliance with the post-approval commitments can ruin everything. Good consulting partner considers post-approval compliance as a next step of the same cooperation, and the systems that got the product approved continue managing it.

  • The example of product approval

Imagine a mid-size manufacturer filing his first product in a regulated market. In the case when there is no regulatory consultation, the usual process will be the following one: the dossier is submitted, formatting issues appear in the validation process, resubmission takes six weeks, and the substance review creates the list of the questions which takes four months to answer because required data is spread between three departments and two vendors.

In the case of consulting partner who participates in developing the strategy, the same product is submitted in a different way. Data gaps were detected a year ago and were filled during the development, dossier passed an internal agency-style review before submission, possible questions were anticipated and answers were prepared before receiving the letter. The product is approved not because of the change in the science, but because of fast approval due to the absence of avoidable problems.

  • Selection of the right partner

All consulting firms do not deliver this result, and when you are evaluating a pharma regulatory consulting company, you should look for the signs in three areas.

First, it is the depth across the lifecycle. A partner who only writes dossiers cannot help you with a mistake in the strategy, and a strategist who has never published an eCTD underestimates the work on the submission. The  range of our services in the field of  regulation include regulatory intelligence and strategy, medical writing, submissions and publishing, artwork and labelling, health authority interactions, and post-approval compliance, so the same team is responsible for the strategy and implementation of it.

Multi-market experience is the second sign. There are some differences in requirements to the FDA, EMA, and health authorities in Asia and developing countries, so a consulting partner who works in these markets every day will notice such differences that a one-market team will not notice.

Third, it is the work of the consulting firm with your team. Regulatory consulting done correctly includes transfer of the knowledge and not accumulation of it. The Commit-Collaborate-Carry approach of Pharmazone reflects this idea, the client team should understand its own regulatory situation and not depend on outside help for each variation.

  • Honest answer on the cost

Regulatory consulting is an investment, and it is correct to ask about the return on this investment. This ROI is estimated in the number of delays that never happens. One avoided review cycle usually gives several months. For the product with significant income, the math is simple.The right regulatory strategy can make the difference between unnecessary delays and a successful market entry. Let Pharmazone help you streamline your regulatory journey with expert, end-to-end support.Â