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WCS Takeaways from RAPS 2015 Regulatory Convergence in Baltimore

This year, I had the good fortune of attending the annual Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence in Baltimore, MD. Being my first Regulatory Convergence, I was excited and unsure of what to expect. As I walked into the massive convention center near the Inner Harbor, I was taken aback by the amount of attendees. I didn’t know where to begin.

This event was truly a convergence, a meeting of the minds, where regulatory professionals with very impressive pedigrees provided interactive sessions covering a host of current regulatory issues.

Having a legal background, I attended the session on “Common Challenges Facing Lawyers in our Globalized Medical Products Industry.” The seasoned attorneys on the panel led an interesting discussion about the necessity of communication between regulatory and legal departments within a company andthe need to anticipate potential issues and addressing them proactively instead of reactively.

I found the session about the Ebola Vaccine Development Response to be fascinating. I felt compelled to sit in on this session, as I live less than a mile from NIH and was watching the helicopter that transported the first Ebola patient to the NIH facilities from my front porch. It was truly amazing to hear how the various agencies came together to execute the approval of the life-saving treatment in such an expedited fashion.

Between the well-executed, informative sessions, the impressive exhibit hall, and the welcoming and friendly nature of the attendees, the 2015 RAPS Convergence did not disappoint. I look forward to attending future RAPS events.

 

International flags flowing in the wind

Preventing Document Legalization Rejection at the Embassy

In its simplest form, document legalization is “the process of authenticating or certifying a legal document so a foreign country’s legal system will recognize it as with full legal effect,” at least, so says Wikipedia.  However, the process can be far from simple.

And for those within a company who are lucky enough to be tasked with handling this process internally, the tangential feat of memorizing each country’s specific requirements can be about as simple as memorizing every bone in the human body for a high-school biology exam.

So I have decided to “throw a bone” to anyone who has experienced the “Unfortunately, we were unable to process your document because..” letter that accompanies a rejected document from an Embassy.  This article will reveal some, I repeat, some, unique requirements of some frequently called upon Embassies that can assuage one’s fear of rejection.

NGO document

How To Deal With Government Entities To Get Your Documents Legalized:

Regulated industries, including but certainly not limited to, Pharmaceuticals, Medical Devices, Biotechnology, and Consumer Products, have a virtual obstacle course of hoops to jump through in efforts to bring their products to market. Companies that have a global footprint continue the hoop jumping in efforts to get the product onto international “shelves.” It is for those additional steps that companies sending product overseas should outsource.

Document Legalization: a process during which documents are navigated through an assembly line of notarizations, certifications, and authentications so that these documents can be used in foreign countries to transact business. It is a “hurry up and wait” game as the documents are passed around government agencies in hopes of getting their stamps of approval. Notaries, Clerks of Court, Chambers of Commerce, Secretaries of State, U.S. Department of State, and Embassies…Oh my!

It is a necessary evil, a niche administrative task that can be confusing and tedious, and it should be outsourced. Here is why:

International Business Map

Managing Document Legalization Through Mergers & Acquisitions

Businesses growing in global markets must continuously manage the processes associated with meeting countries’ regulatory requirements for the sale and distribution of their products. Over time, a company may establish a significant library of authorizations and authentications for legal operation in each country where it does business. But, what happens when a company merges with or is acquired by another?

Here are a few actions we recommend:

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Embassy closings for the upcoming Eid holidays

A number of Embassies in DC will be closing in observance of the Eid-al-Adha holidays which could affect the document authentication process in terms of turnaround times.

Below is a working list of the Embassy closings.  We shall update it as we receive this information from the Embassies.

BAHRAIN

  • Friday and Monday

BANGLADESH

  • Friday and Monday

EGYPT 

  • Monday

IRAQ

  • ALL of next week – 10/6 – 10/10

KUWAIT

  • Monday, Tuesday and Wednesday

MALAYSIA

  • Monday

NIGERIA

  • Monday and Tuesday

QATAR

  • Monday

SAUDI ARABIA

  • Monday, Tuesday and Wednesday

UNITED ARAB EMIRATES

  • Friday

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NATIONAL US-ARAB CHAMBER OF COMMERCE

  •  Friday

And Eid Mubarak for all those celebrating!

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