WHAT WE DO BEST

 

All of our services

  • Alternative Raw Material Sources
    Opportunities to obtain alternative raw material sources of manufacturers with Good Manufacturing Practices Certificates awarded by National and International Sanitary Authorities.
  • Search and Selection
    Our search and selection of active ingredients is based on the constant modernization of the market and legal-regulatory requirements recognized and accepted by COFEPRIS (GMP EUR, TGA ANVISA and CPP).
  • Technical Consulting
    Development of pharmaceutical formulations, unit operations and raw material characterization.
  • International Certifications
    We count with international certifications of raw materials issued by regulatory authorities abroad recognized by COFEPRIS. We help international manufacturers to comply with Mexican's Good Manufacturing Practices and obtain COFEPRIS GMP certification.
  • Support Registration Documentation
    We assure worldwide quality certifications, which include: COFEPRIS GMP/Mexico, FDA/United States, ANVISA/Brasil, Health Canada, EMA European Community, TGA/Australia.
  • DMF's
    We have the DMF's (Drug Master File) for all raw materials we handle here, which are available to the customer for the registration of the drug.
  • New Products
    Proposals development projects for new products.
  • Quality Assurance and Regulatory Affairs
    Our Quality Management System be applied efficiently according to International Guidelines of ICHQ7A and our closely related local regulations: NOM-164-SSA1-2015 and NOM-059-SSA1-2015 which allows us to offer great customer service and technical support directly related to the quality, effectiveness, and security of the product.

Quality Management System

 

Our personnel has ample experience in the Pharmaceutical Industry. Allowing the Quality Management System be applied efficiently according to International Guidelines of ICHQ7A and our closely related local regulations: NOM-164-SSA1-2015 and NOM-059-SSA1-2015 which allows us to offer great customer service and technical support directly related to the quality, effectiveness, and security of the product.

Our Quality Management System is based on compliance with current regulations as well as other legal provisions and sustained by operational and support processes, which are planned and carried to term under controlled conditions, always based on a continuous focus on improvement.