Objective & Vision
Working with us
Repharm Services
Finish Medicine
Bioavailability. & Bioequivalence
Crisis Intervention
Repharm Consultants

Crisis Intervention:

Are YOU presently concerned or involved in any of the following?

  • Recently received noice for upcoming ministry audit
  • Received a Warning Letter from ministry of health
  • Received non-conforming observations from an external audit
.It is important that you prepare and respond to each of these situations carefully and thoughtfully. Failure to properly act in these situations could possibly result in your business being shut down, criminal/civil actions being filed, and/or huge financial losses. We have seen many companies proceed without guidance and have ended up wasting a lot of time and money by not involving expert assistance during these critical situations.

Repharm consultants can assist pharmaceutical companies in these situations. Since time is critical, Repharm has created an emergency hotline, which can provide you some initial assistance in understanding what is going on and how to proceed. You can also send us e-mail at crisis@repharm.com.pk.

This initial consultation of up to one hour will be done at no charge. After the first hour, a fee will be discussed and approved. If you are not satisfied with Repharm services, you may cancel at any time and pay for only the time you used.

Sample Situations

Given that specific situations will vary from one client to another, below we have provided situations that are representative of companies and situations, whrere we can support our clients;

Situation #1 - Postpone a MOH audit
Situation #2 - Respond to an MOH Audit
Situation #3 - Respond to an MOH Warning Letter

Situation #1 - Postpone an MOH audit
The MOH just contacted you to let you know that they intend to inspect you facility next week; you are not sure why they are coming and if you would be able to pass the inspection. If you get Repharm involved immediately, Repharm may be able to get an extension for the upcoming audit.

Repharm will ask the MOH certain questions to ascertain the MOH's objectives with their audit. Based on the response of the MOH, we can help you to craft a strategy to have the audit postponed or to prepare for the audit itself.

Prior to the MOH audit, we can conduct a mock MOH inspection and provide you with a list of action items that have to be addressed, so you are better prepared for the official visit. At your request, Repharm can also be present during the MOH inspection to ensure that the inspection proceeds properly and to assist in providing immediate strategies for addressing problems that the MOH finds.

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Situation #2 - Respond to an MOH Audit
The MOH just finished their inspection and you just received the List of Observations from auditors from Ministry of Health. This List of Observations contains deviations that the MOH found during their visit.

Repharm will provide you with an explanation of these deviations, what their implications might be, and what regulatory actions the MOH may likely take against your company (i.e. Warning Letters, Seizure, Injunction).

A proper response to all MOH observations must be done within matter of days and must be written in a specific manner to greatly reduce the likelihood of receiving a Warning Letter in the future.

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Situation #3 - Respond to an MOH Warning Letter
The issuance of a Warning Letter is a very serious violation and should not be taken lightly. Your response to the Warning Letter has to be made in such a way to provide a good understanding of the situation, but it has to address the actions that your company has taken or will take to assure compliance.

Repharm will provide you guidance in reviewing the Warning Letter, determining what underlying concerns there might be and provide a strategic plan on how to respond to the letter. The decision to meet with the MOH, at this time, may very well be warranted. These options, as well as all others, could be discussed.

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