Effort technical file creation?

[Vetty007]

Hi,

as a consultant, I always have discussions that the calculated effort for creating the technical file is far too high; this certainly varies greatly depending on the quality requirements and complexity of the product. I'm now having more and more problems, that I know how long the different tasks takes me to complete them, but I'm always amazed of the expectations of customers and I don't really enjoy it, to be almost insulted and supposed to be taking an artificially long time to performe the task, esp. as I even think to be very fast. The situation is therefore more than unpleasant for everyone and before I give up here, I would be interested in other assessments of what an acceptable amount of time is for creating a complete technical file (TD).

I usually estimate 300-350 hours including CER and everything around it, such as organization and meetings, so far this has usually worked out well. For a project with several files, I was told to offer it for 200 hours, but then this was even further reduced to only 100 hours. I then rejected to do the project several times as I considered it impossible to create a complete TD in that time. Unfortunately, I allowed myself to be persuaded, under the premise that everything would be kept as efficient as possible and that I would create all TDs. In the end, I came up with a kind of mixed calculation that was just acceptable for myself and then unfortunately got involved in the project. Well, actually I should have known, that the requirements and wishes are just as high, if not even higher (after all, the customer decided to commission one despite the price) for the "normal" price, despite they have a bargain price, and dissatisfaction is therefore pre-programmed.

Now that it has taken me 3 days to create each file, the customer is already dissatisfied because in his opinion this is too long (or as he complained, that he has already spent a lot of money but doesn't have anything finished in his hand yet) - I am amazed and rate this as very quick. For the separate documents that belong in the file (risk management report, PSURs, CER) and still needs to be created, I would now have a budget of almost 80 hours left and, in my opinion, this will be just within the realm of possibility to finish the file. I don't see any room for meetings or larger discussions etc. here, even though these would actually be necessary. But the customer now expects me to get by with even less time and at this point, I really have no idea where I should save time. I don't twiddle my thumbs at all, I don't waste time with research, etc. and can write the required texts fluently in one go. Nevertheless, it just takes time to write everything, even if you already have it in your mind and know what you're writing - just documenting various database searches takes time or reading the relevant publications and then you have to defend yourself that you charge a fix price of one hour for reading, rating and summarizing larger publications (> 10 pages). Even though I have easily spend 2-3 hours or more for this, but feel sorry for the customer that he needs to pay the hight effort to read several publications.

I would therefore be very interested to know what is an acceptable amount of time for creating a complete technical file and also for a CER. The last actually takes me at least 120-160 hours (no big toxicological calculations needed/ simple substance based device, e.g. wound dressing or irrigation solution) plus the literature research and evaluation. Are these actually times seem to be far too long or are they supposed to be absurd and far from reality?

I'm really looking forward to your opinions and would like to say thank you very much for reading and also for commenting in advance

 

[yodon]

I don't think giving out a number without understanding the project is probably not helpful.

As a consultant myself, "big blocks" of hours are generally what gets questioned. Have you tried to itemize the work and break it down to 20 - 40 hour chunks? That's usually something reviewers can get their heads around. We also load up on the assumptions that drive our estimates. Those are then risks that are managed ("oh, you DON'T have this documentation, then we have to adjust the estimate")

Who is cutting your estimates from 350 --> 200 --> 100 hours? That doesn't seem responsible without data. Low-balling rarely works out for anyone.

We do add specific time for "project management" to cover all the time needed to provide status and answer customer questions.

 

[Vetty007]

Thank you for your Opinion and of course you are right, that for numbers knowing the project in details is needed, but I think even without this its possible to estimate very largely, what could be a potential effort needed.

Initially I have given almost every document needed with its effort, even if its just a few hours. The only thing I haven't broken down further into the effort e.g. per chapter is the CER, and this is the only aspect where I have a large package of hours. I'm very reluctant offering a literature search as the effort can only estimated correctly once the research has been done (in 2 databases) and the literature is roughly examined, so that you know how many of the publications you have to read. Actually, an offer should therefore correctly be made in these two steps - but up to now I always had to make a corresponding offer in advance, with the result that I had already completed the first part in order to be able to make a correct offer for esp. the second part of the work. If the offer wasn't accepted, the whole work was in vain, which is just as unsatisfactory as if you miscalculated the effort and are later stuck with your offer.

The problem in the actual case was, that my effort is 300-350 hrs per file, but then a partner I work with, recommended me and said, that I am an expert for these kind of products and that I will do the files in 200 hrs and I was asked to prepare a corresponding offer. The client then said, he would like to start the project, but in the first meeting told me, the budget is only 100 hrs. Since the time budget seemed more than inadequate to me, I rejected the project several times, but then allowed myself to be persuaded as I felt sorry for the customer as I can understand, that its a lot of money for a small company with several products.

Yes, project management time makes absolutely sense and I usually always include such time - but in this specific case there is no budget at all as the 100 hours are actually hardly or not even enough to create all the documents. Even if all the synergies are used, that arise, it is not the case that the work would be significantly less with several TDs and that you could therefore simply save 50% of the work.

Since I found the project itself exciting and still do, I got carried away. However, due to countless discussions and increasing expectations from the customer while at the same time further reductions in the available budget, the whole thing is becoming an increasingly loss for me, and everyone involved is dissatisfied. I have no idea how to solve this, I certainly don't want to be constantly told that I'm a cutthroat, esp. not as the whole thing is a loss for me. I can also use my time for clients who are happy to pay for my (full)time. However, I have no idea how I can pull myself out of the middle of the project and as a consultant you don't actually want to leave your client alone with the rest of the work and that's an absolute worst case. But the question is how long you will torture all involved, if you have such contradictory opinions.......