Steps to get ready for an overseas on-site GMP inspection for pharmaceutical products in Singapore

With the Covid-19 outbreak, many countries have implemented travel restrictions which have delayed inspections and business trips. Although business has slowed down, it’s a good time for us to review and realign our market strategy to the current situation. If you are currently an overseas company having plans to get your manufacturing site to be  […]

Love- Hate relationship between Supplier and Distributor Part 2/2

Following the previous post, today we will be discussing 3 common problems encountered by suppliers when dealing with distributors: Lack of commitment towards timeline Time is money. Whenever a timeline is given to feedback about a product, we should honour the timeline unless there are some unforeseen circumstances. Often, suppliers get email commitment from distributors […]

Love- Hate relationship between Supplier and Distributor Part 1/2

Traditionally, when a medical company would want to expand their territory , the first thought would be to find a appointed distributor that would handle everything from registration, marketing, distribution and to logistics. These are some of the common problems observed while dealing from both sides: Three common problems that are happening always from Supplier […]

7 steps to solve regulatory issues

Managing regulatory obstacles is a key essential factor in expediting the approval of the products. Yet it can be daunting when we receive pages long of questions. Let’s look at the general workflow for solving regulatory issues. Categorize the questions into either administrative or technical. This will enable us to allocate our time better in […]

How to set up a Quality Management System for a small company

It’s time of the year again where perhaps this question of setting up a Quality Management System has come up to your mind. Whether it is due to a new business direction or complying to upcoming regulations, it’s always good to start early. Let’s go through the 5 steps to do this quickly. Understand what […]

Commercializing your product through regulatory classification

Healthcare industry remains to be one of the most regulated among all businesses. So how do small companies remain competitive in this regulated world? Today we will discuss about ways to maximize your product value through regulations. We need to look closely at each category of classification: Medical Device, Drug Product, Cosmetics and supplements. A […]

What is a ASEAN CTD ?

In my previous blog, we shared briefly on 5 points to look out for when preparing a dossier for submission. In the process of compilation of documents, you often hear your Southeast Asia partners mention about a specific format for submission which is the ASEAN CTD. So what is ASEAN CTD? ASEAN CTD stands for […]

5 quick questions to check before regulatory filing of pharmaceutical products in ASEAN

To many of the principals out there, ASEAN remains one of the biggest untapped market . But yet, there are many “mysteries” surrounding the ASEAN’s regulations. for filing of pharmaceutical products. Common questions encountered are like: What are the regulatory requirements? What are the obligations as a marketing authorization holder? What business model would be […]

List of essential documents for ISO 13485:2016

With the implementation of ISO 13485:2016, many companies are rushing to comply to the latest addition. The Reg Consultants Pte Ltd has prepared a list of essential documents for medical device companies to download in implementing and preparation of a transition audit for ISO 13485:2016. So subscribe now to get the free checklist over here!

Do regulatory personnel need to be commercial savvy?

When I used to work in big corporations in the regulatory department, the mindset was to do what we need to do in our department and we don’t really need to know so much about the other operations of the company. Apart from dealing with close deadlines, we would have to manage our “commercial colleagues” […]

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