监管服务

Regulatory compliance service
 
Simagchem provides regulatory and compliance support as a competitive advantage to both suppliers and customers. Our experienced compliance and auditing team offer comprehensive technical support and scientific reinforcement.
 
●          Simagchem’s Regulatory group ensures that all Pharmaceutical, Nutritional, and Food products meet their applicable monograph/standard (USP/NF/EP/FCC) and are always labeled and packaged correctly.
●          Simagchem’s Regulatory group has the expertise to file and maintain Drug Master Files and Certificates of Suitability (COS) in virtually any regulated market.
●          Regulatory submissions filed by Simagchem are prepared by our HongKong and Xiamen, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.
●          All DMF/COS submissions are filed in Common Technical Document (CTD) format. Simagchem’s expert regulatory group has the capability of filing electronic DMFs (eCTD) to support the fastest approval possible for our customers.
●          Our close relationships with our represented manufacturers allows us to respond quickly and accurately in all aspects of regulatory submissions.
●          The experience of our Regulatory staff and good working relationship with the FDA, enables Simagchem to address Regulatory issues and expedite regulatory approvals quickly.
●          Simagchem’s Regulatory group is well versed in the GDUFA law and ensures that all required Simagchem represented API suppliers have Self Identified with FDA and Facility Fees paid. In addition, Simagchem insures that all submitted Drug Master File fees are paid and that they pass initial FDA review in a timely manner.
 
REACH Regulation – taking our responsibilities seriously
The Registration, Evaluation and Authorisation of Chemicals (REACH) in the EU is one of the strongest regulatory changes ever to hit the chemical industry. REACH regulations entered into force from 1st June 2007, followed by a progressively more demanding implementation programme. Pre-registration activities involved more than 10,000 substances, marketed in the EU by Simagchem. We're now moving to the next phase, and Simagchem continues to play a constructive role in the implementation of REACH.
In addition to management of our own REACH compliance,Simagchem offers a number of services to help our principals and customers comply with REACH, providing practical help and information – for example, acting as Only Representative on behalf of non-EU companies and providing consulting services such as our REACH Advisor Service.
SIMAGCHEM is preparing for the pre-registration of its chemicals and reagents under the REACH (Registration, Evaluation and Authorization of CHemicals) regulation.
 
Please refer to the success case of REACH pre-registration portfolio as the left PDF box.