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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.

 

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:

Important Payment Change from the Embassy of Qatar

Starting tomorrow, 12/12/2014, the Embassy of Qatar will no longer accept payments via cash, check, credit card or money order.

All legalization payments for all documents both legal and commercial will have to be made to the Embassy’s bank account.  Once the payment is complete, one must remit the deposit slip accompanied with the document to the Embassy’s consulate to be processed.

We certainly understand that this is not any easy transition for those looking to legalize documents with the Embassy of Qatar.  But we are here to help so feel free to contact us if you have any questions.

In the meantime, you can learn more about the Embassy of Qatar’s legalization procedures here.

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WCS Offers Expert Advice in Publication of the Regulatory Affairs Professionals Society

WCS published an article in July edition of Regulatory Focus entitled, “Document Authentication for Product Registration/Regulatory Submissions Outside the US.” The educational overview outlines steps in the certification process for health and medical product companies, and provides an example.

Regulatory Focus is the flagship publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.