After long‑term R&D breakthroughs, compliance‑system refinement and full‑process technical‑documentation collation, FITAKH Pharmaceutical Biotechnology Co., Ltd. has officially completed full‑set MDMF filing and archiving for nine core regenerative medical‑aesthetic raw materials, providing dedicated support for industry partners developing Class‑III injectable medical devices.
The completion of full MDMF filings for these nine raw‑material products marks an all‑round upgrade of our company’s capabilities in raw‑material technical research, quality‑standard control, regulatory compliance support and technical‑documentation services. We have reached a new milestone in raw‑material supporting services for the industry, and are ready to deliver stable, compliant and full‑chain integrated raw‑material technical support for global aesthetic formulation manufacturers.
The Master File (MDMF) serves as the core statutory‑technical foundation for aesthetic raw‑material support, formulation registration application and product submission for testing. A complete set of MDMF indicates full compliance of full‑chain documentation, including raw‑material process research, impurity analysis, stability testing, quality standards and traceability statements. It is a critical prerequisite for formulation clients to launch new products and complete regulatory registration.
This time FITAKH has completed the full MDMF setup for nine flagship raw materials in one go, covering all mainstream tracks including aesthetic filling, mesotherapy repair and regenerative anti‑aging. The detailed filing records for these nine compliant raw‑material MDMFs are shown below:
Technical documents for all raw materials are standardized and normalized, with completeness and rigor meeting the review criteria for Class II & Class III medical device registration.
We can directly provide full supporting documents for long-term cooperative Class III injectable manufacturers, greatly shortening the cycle of new product registration, inspection and market launch.
By delving deep into raw material technical research, we avoid common industry pain points such as missing registration documents and discontinuous process data at the source, lowering compliance risks for downstream clients.
From supplying documents for single raw materials to forming a complete master file matrix for 9 core products, FITAKH has achieved a leap-forward upgrade in compliant raw material technical services, forming a full closed-loop service covering "raw material R&D – full compliance document support – technical delivery for terminal preparations".
For years, FITAKH Pharmaceutical & Biotech has focused on R&D of high‑end regenerative aesthetic raw materials and supporting compliance services. It keeps delivering mature and compliant raw‑material solutions for leading injectable‑device manufacturers in the industry, and has built long‑term, stable and in‑depth strategic cooperation partnerships.
Leveraging our in‑house professional R&D laboratory and experienced team of regulatory compliance specialists, our company delves deep into raw‑material formula research, data validation and compilation of comprehensive technical documentation. All technical materials are independently developed and repeatedly verified, so as to guarantee the rigor of raw‑material technical data and completeness of biocompatibility demonstration from the very source.
In the future, FITAKH will increase investment in innovative raw‑material R&D, expand full‑category MDMF reserves and enrich its high‑quality compliant raw‑material portfolio. Supported by standardized full‑set documents and professional technical services, we will cooperate with worldwide injectable‑device partners to tap into the regenerative aesthetic market and promote standardized, high‑quality growth for the raw‑material sector.
