Normative Compliance

CADERSO's commitment is to support the pharmaceutical industry to advance in compliance with the regulatory systems that exist at a national and international level.

We are an ally to our clients by helping them implement and maintain an effective Quality Management System.

Complying with the norm and its regulations is a constant, relentless task.

Our team of specialists help our clients to achieve this through our well-established work process that leads to a final report that involves an exhaustive analysis to generate conclusions categorized by priority of attention.

Compliance Services

Requirement Fulfillments

1. Internal and supplier audits

We evaluate the existing quality management program to determine its compliance with company policies, contractual commitments and/or statutory and regulatory requirements.

  • NOM–059 SSA1-current - Good Manufacturing Practices for Medicines.
  • NOM–241 SSA1-current - Good Manufacturing Practices for Establishments Dedicated to the Manufacture of Medical Devices.
  • NOM-249 SSA1-current - Sterile Mixtures: Nutritional and Drugs, and Facilities for their Preparation.
  • ISO-9001 SSA1-current - Quality Management Systems — Requirements.
  • ISO-13485 SSA1-current - Sanitary Products. Quality Management Systems. Requirements for Regulatory Purposes (Medical Devices).
  • 21CFR820 – FDA Current Good Manufacturing Practice.

Maintenance of the QMS

  1. Diagnostics

    2. Definition of the current state through the evaluation of the company's quality management systems to find gaps against the applicable standards in its respective industry at a national or international level.

  2. Gap Audits

    3. They help review very specific processes that the client has detected are having an impact on the internal QMS. They are carried out in accordance with the procedures of the client, of a specific system, of the regulatory institutions or of CADERSO's own procedures.

  3. Remediation plans

    4. What did I do wrong? How can I fix it? Plans derived from the findings found in gap audits or even internal audits. A remediation plan allows risks to be managed correctly with a functional and effective plan, setting deadlines that allow reaching the standards set by the regulations.

  4. Follow-up in the executation of remediations

    5. With a team of expert consultants, we accompany our client in the proper execution of the remediation plan.

  5. Closure of remediations

    6. Mock inspection - Audit to verify compliance with the remediation plan with a similar approach to that applied by the authority.

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