Pharmaceutical Regulatory Services
Benefit from our vast knowledge of healthcare regulatory compliance in accordance to Pharma and local DCA (NPRA) guidelines. We can assist you with complete solutions for product registration from start to finish, including:
01.
Meticulous ‘Gap Analysis’ Review
02.
Registration of Cosmetics and Its Variants
03.
Preparation and Review of Module 1 CTD (Common Technical Documents)
04.
Preparation and Submission of Responses to Malaysia’s NPRA Evaluation Queries
05.
Regular Updates of Timeframe and Possible Challenges Throughout Registration Process
06.
Classification Review to Determine Product Category Before Registration
07.
Comprehensive Document Reviews – BMF (Biologics Master File), DMF (Drugs Master File), Process & Analytical Validation Reports, Stability Study Report, Certificate of Analysis and Others
08.
Be Regulatory Contact Liaison between applicant and the Malaysia Drug Control Authority
09.
Advisory of Artwork and Labeling Amendments and Product to Ensure Regulatory Compliance
10.
Dossier Compilation as per ASEAN Technical Guidelines / Malaysia Specific Format