Case Studies

Urgent action to obtain distribution license for food products


Situation:

A Pharma distribution company receives a communication from the Authorities requiring them the need to have Food Distribution Authorisation urgently to carry on the business of distributing special foods, chewing gums

Task:

The Company had the following options: Assign the task to in-house personnel, to this it had to allocate financial

Action & Result:

This solution was instrumented in three ways: identification of the foods, indicate the separations

Joint collaboration with engineering firm in the setting up of a meat processing plant


Situation:

Yerfis was approached by an engineering firm who had won the contract to build a meat processing plant

Task:

Consultant with regards to the sanitary aspects of the project.

Action & Result:

What started as punctual collaboration, ended up in the embedding of one of our team, at the customer’s request. The heath risk factor analysis, evaluation, evaluation of the validation of the traceability software, personnel training and developing SOPs was assumed by Yerfis. Once the documentation was presented, Yerfis was responsible for following it to approval.

Optimization of a product range


Situation:

Yerfis was approached by a cosmetic firm who wanted to obtain more return from their product range

Task:

Increase product return by at least 20%.

Action & Result:

After a careful study of the product range, markets & current trends a development plan was structured. The first aspect was to ensure that the expiry date of the product was correctly identified to optimize product return. The company did not have the know-how or installations to carry out stability studies. Yerfis applied Pharma knowledge to this & negotiated all the aspects of these studies. As a result expiry date of all formulas was extended and more unstable formulas where improved to obtain a 5 year expiry date for all. The next phases of the development plan are currently underway.

Making an ointment plant GMP compliant


Situation:

Client had a plant that produced around 1M units of its own brand of cosmetics and was considering a new plant that would be GMP compliant as it considered its current structure totally unviable. The client had started to work with a local engineering firm towards this project but found that it lacked the expertise to complete the task.

Task:

To work with the client the engineering firm to carefully study its processes, space & resources available as well as its personnel.

Action & Result:

A complete plan was agreed where an executive commission was created so as to coordinate the plan, giving the customer the key control with solid partnership. The objectives were clear, for the client, we included another one, self sufficiency. The result of this was that 20% of its available resources were reused; the plant was made in line with GMP guidelines with a 20% saving from the initial budget. Personnel training of the three key responsible was in such a way that they could pass down this to the rest, and they were responsible for drafting out the SOP and training, under Yerfis supervision. Yerfis placed the skeleton that was as close as possible to the way the client worked and its structure, and it was their own staff that filled the rest. The client’s plant passed the GMP inspection and currently runs unsupervised and only yearly audits are executed as a check of compliance.

Gaining control of your cosmetic Formulas


Situation:

Successful cosmetic formula developer that commercialises its product has been relying on his manufacturer to keep its RA up to date. They want to change manufacturer but feel uneasy on letting the new one possess the control of their RA in the face of the coming regulatory change.

Task:

They contemplated three options: incorporating the know-how, in-house training, or outsourcing. For this reason they contacted Yerfis.

Action & Result:

Evaluation of the cost & benefits of each option and the foreseeable workload in view of their future developments. The chosen option was help with the transfer and in-house training of a member of staff. The current manufacturer was reluctant to transfer the information and the client decided to run over them in as much as possible. Yerfis obtained the information from the Authorities that permitted this know-how to be in the client’s possession.

Type I variation denial, saving the moment


Situation:

MA holder wanted to change the manufacturer of its creams. Its own in-house team prepared and summated the IA, with the available GMP certificate that was out of date as the new one had not yet been issued. The AGEMED rejected the request based on the expiry date of the presented GMP certificate.

Task:

The problem was that the new one had not yet been issued and a delay was costly.

Action & Result:

The client was happy to present a first appeal that was prepared by us based on the use of the Administrative Law that indicates that if the authority has knowledge of a fact, this does not need to be presented. The appeal was duly estimated and the IA was obtained. This allowed the client to reduce cost by this effective outsourcing that would otherwise be delayed another year

Drafting out a licensing contract and turning sweet sour moments


Situation:

Yerfis was approached by an engineering firm who had won the contract to build a meat processing plOut-licensing company wanted to sign deal with three Pharma companies in Spain for its product but wanted a single contact for its RA, also needed advice on how best to adapt its standard agreement. The client thought that Arbitration by the International Chamber of Commerce, and letting each future license holder could be the best option.

Task:

Study the best possible option for the client for effective protection

Action & Result:

After careful examination we proposed that the contract would be best served if arbitration was left to the court in the client’s client residence as a cost effective & effective method. Other changes were made to include Bankruptcy clauses, floor price. The RA was solved by allowing Yerfis to act as the liaison with all of the client’s clients so that its regulatory team had a simple and single way of dealing with matters. The results were that the local MAs were obtained in a smoothness process with the compliments of the RA department, and one of the client’s clients turned sour and we were able to transfer his MA to another client when faced with real possibility of effective litigation. The client now has implemented this policy in his territories of activity.

Entering the Spanish market in a legally diffuse environment


Situation:

Generic company had been stuck for a solution due to the indecision of the Spanish agency with regards to the Local Representative status and the non local regulation of this matter. Its previous attempt had involved expenses in consulting and lawyer with no result.

Task:

To get the LR status as soon as possible so it could start its operations.

Action & Result:

We inquired in the Agency and Law on the ways to get the customers objective and took control of all the operation drafting out all the needed documentation, with no work load on the customers departments, we filed the submission within two weeks and followed it up to approval. The client now has an effective operation running and has decided to leave all Spanish RA in our hands.

Importing from Spain, how to reduce cost & time through streamlining


Situation:

Client wanted to import from Spain certain molecules and obtain distribution rights. Before he would search for the suppliers meet with the individual companies reach agreements with each one of them and arrange imports from them individually. This was time consuming and the imports had higher transport costs as it was done from each individual company.

Task:

To streamline the operation.

Action & Result:

Yerfis proposed unifying this structure and groping of purchases into four yearly shipments instead of the sixteen previous ones with our coordination. With regards to new licenses this regroup strategy allowed more companies to be considered and due to our inside knowledge better purchasing prices could be obtained. The client found that the initial objectives, cost-cutting and time-saving had been solved and found also that he could totally forget about the supervision of the Spanish operation and dedicate himself to other markets as the operation was smoothly running with Yerfis.

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