Consultoría - JLM Projects

consultancy

At JLM Projects, we specialize in pharma consulting and offer fully customized solutions based on your business needs. Our services help you achieve total regulatory compliance, increase efficiency and promote continuous improvement of your organization.

We provide a full range of services within the scope of the pharma industry, assisting and supporting clients in meeting their business goals in the implementation of quality management systems, projects and new challenges of change. We provide support to identify and implement good laboratory practices in quality control and quality assurance areas.

Our services cover:

Development, implementation, improvement, monitoring and control of quality management systems based on ISO standards and Good Practices (GxP) according to national and international regulations: WHO, MERCOSUR, FDA and EMA.

Preparation of tailor-made documents and records for operations carried out by our clients. Documents cover quality manuals, procedures, work instructions and records.

Design, start-up and coordination of new local and international operations, whether in-house or outsourced operations.

Quality Control Support:

Process improvements in Quality Control laboratories.

Advice on:

-Stability studies

-Validation of analytical methods

-Transfer of analytical methods

-User Specification Requirements (URS)

-New lab equipment acquisition

Quality Assurance Support:

Validation Master Plan.

Equipment qualification, calibration and maintenance programs.

Facilities, equipment and analytical instrument qualification protocols (FAT/DQ/IQ/OQ/PQ).

Design, direction and revision of validations (processes, cleaning and analytical methods)

GxP Manuals.

Standard Operating Procedures.

Deviations, nonconformities and CAPA systems.

Change control systems.

Advantages for clients

Our consultants provide strategic leadership and hands-on expertise which ensures a high level of support to help you meet your goals.

Your company will achieve fully customized project solutions based on your needs.

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