Consulting Services

By the Book provides assessment on implementing and optimizing Quality Management Systems, current Good Manufacturing Practices (cGMP), Good Automated Manufacturing Practices (GAMP), and Good Laboratory Practices (GLP). We also provide Assessment on local and international Regulatory Affairs, and we take the corresponding steps.

 

Our Consulting Services are oriented to:

  • Pharmaceutical Industry
  • Cosmetic Industry
  • Veterinarian Industry
  • Food Industry
  • Medical Products Industry
  • Household Care Industry

and provided to:

  • Third party companies
  • Input suppliers
  • Distributors

Our services are:

 

Quality Audits:

By the Book helps your company by developing:

 

  • cGMP, GLP and GAMP Compliance audits, aligned with the local and international requirements:
    • At your company.
    • At the third parties plants that develop, control quality, manufacture, package, import, export, warehouse, and distribute your products.
    • At the input supplier plant.
  • Audit Reports
  • Corrective and Preventive Action suggested Plan.
  • Monitoring the implemented Corrective and Preventive Actions.

 

Document Writing

By the Book can help you writing:

 

  • Standard Operating Procedures (SOPs).
  • Raw material, packaging and finished product specifications
  • Other documents related to cGMP, GLP y GAMP.
  • Documents related to Regulatory Affairs.

 

Regulatory Affairs

By the Book´s advice on regulatory requirements, makes sure that corresponding steps are promptly accomplished. We can offer you:

 

  • Advising about different regulatory requirements for pharmaceutical, cosmetics, food products, medical devices and household products.
  • Writing of product dossiers for registration.
  • Submitting and follow-up of product dossiers in local agencies.
  • Assistance in the registration of plants and structural changes.
  • Advising on Product Advertising.

 

ISO Standards

By the Book helps your Organization through the implementation and audit processes of Quality Management System under ISO Standards .