Your Market Access Partner in Malaysia
Helping global animal health companies enter, grow and succeed in Malaysia.
Regulatory Support
Guidance on Malaysia's animal-health regulatory requirements.
Product Registration
Registration coordination from submission to regulatory follow-up.
Local Representation & Licence Holding
Local representation and licence-holding support for international manufacturers.
Import & Distribution
Local supply and distribution to support market entry and growth.
Turning a Product Opportunity into Market Access
Once we identify a promising product, our regulatory team works with manufacturers to navigate the requirements for entering the Malaysian market.
Regulatory Support
We help manufacturers understand regulatory requirements and prepare the necessary documentation and technical information.
Product Registration
We manage the product registration process, from document preparation and submission through regulatory follow-up.
Local Representation & License Holding
For international manufacturers requiring a local regulatory presence, Fisterra can act as an Authorised Local Representative (ALR) and, where applicable, a Marketing Authorisation Holder (MAH). This provides a local point of contact for regulatory matters while supporting a more flexible approach to product registration and distribution.
From Market Opportunity to Market Growth
Entering a new market takes more than product registration. We work with our partners through each stage of the journey, from identifying market needs and the right opportunities to building the market.
Identify the Opportunity
We identify suitable products and manufacturers by looking at market demand, unmet clinical needs, product potential and regulatory feasibility.
We emphasize
- Unmet clinical needs
- Market demand
- Product potential
- Regulatory requirements
- Existing competition
- Manufacturer & product range
Establish Market Access
We manage the regulatory and licensing requirements needed to bring suitable products into Malaysia.
We handle
- Product registration
- Regulatory submissions
- Licensing requirements
- Import requirements
- Regulatory documentation
Build and Grow Together
Once products are successfully registered, we support product introduction, distribution and market development.
We support
- Distribution
- Product & technical support
- Customer engagement
- Product training
- Market development
Why Partner with Fisterra?
Local expertise. Regulatory know-how. A partner focused on long-term growth
Local Market Understanding
We understands Malaysia’s animal health markets, regulatory environment and customer landscape
Practical Regulatory Support
We help manufacturers navigate local registration and regulatory requirements
Long-term Partnership
We support product introduction, distribution, and market development beyond registration
Looking for a Partner in Malaysia
Local expertise. Regulatory know-how. A partner focused on long-term growth