PRODUCT REGISTRATION CONSULTANCY
Our team are experts healthcare consulting specialising in regulatory-related matters.
Our regulatory services include:
1. Product registration (Health Supplement, Traditional Medicine) and Cosmetic notification with NPRA
2. Latest trends in the supplement/traditional industry
3. All regulatory related matters
- formulation checking
- dosage
- product name background check & feasibility
- issuing bodies for GMP/Free sale cert/CPP
- product category (classification)
4. Advice on post marketing requirement, type of tests that has to be conducted
5. Product development - advice on product formulation and newest ingredient information
6. Post-registration: Variation, Change of manufacturing site (COS), Change of product holder (COH), product renewal.
7. Product classification
8. Food labelling (with Food Safety and Quality Programme (BKKM), MOH)
PERSONAL
Doing regulatory is not all about dossiers, references and computers. Regulators need human contact as well. Communication is important. If you need someone to talk to, drop us a message. Regulatorylens is here for you.
INDUSTRY
At most times, regulatory and the rest of the healthcare industry don't see eye to eye, even in the same company. Regulatorylens wants to bridge the gap (between regulatory and the rest). We can attain common ground by working together and understanding each other.
THE AUTHORITY
To understand the country's regulatory authority (e.g. NPRA), we have to be in their position. The Authority is a safeguard for product access to the market. Regulatorylens can help to overcome any challenges by forming strategies that fulfill all regulatory requirements.
Services
We provide services as below
ENQUIRY
For a free consultation, drop us a message, call, WhatsApp or email us:
Call/WhatsApp: +6011 1025 3721
Email: regulatorylens@gmail.com
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ORODISPERSIBLE TABLET
- Featured
Orodispersible tablet is a new dosage form that has been accepted by regulatory authorities for health supplements. Recently, there was a controversy where a probiotic in orodispersible tablet was rejected by a regulatory authority because probiotics work in the gut and not systemically.
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What is the function or benefit of orodispersible tablet versus conventional tablet? Orodispersible tablets are solid unit dosage forms, which disintegrate in the mouth within 1 to 3 minutes in the presence of saliva. This type of delivery helps certain population groups such as pediatric and geriatric population where swallowing is a matter of problem.
So, evidence out there is plenty to show that in general, orodispensible tablets helps with the swallowing of the product. Was the regulatory authority correct to reject the probiotic in orodispersible tablet form specifically?
The Science Behind Immunity and Gut Health through POSTBIOTICS
What do you think of postbiotics?