Ensure compliance with quality standards in your organization with consulting services, process validation and training
Medicines
Medical Products
Cosmetics
Pharmaceutical
Industry Suppliers
R&D&i Institutions
We understand that there are many situations that may be hindering the growth of the Quality Management area or your professional goals:
- lack of technical staff,
- poorly qualified employees,
- high staff turnover,
- deficient culture of knowledge transfer and intra-organizational learning,
- lack of quality certifications and validations required in your sector,
- lack of updated training necessary for your company's staff or for you to get the job or career advancement you desire.
When the sector is highly competitive and regulated,
keeping up with the latest developments is vital
By finding quality solutions adapted to the reality of your company and its budget you will be able to:
Increase the efficiency and productivity of the activities you perform.
Save time and money by
optimizingr your work
circuits.
Get the required certifications and validations.
Enhance your work
by training your work
team.
At TH asesores, we design solutions that allow adding value to the development and manufacturing processes of healthcare products.
- We facilitate competitiveness and compliancewith national and international standards through Quality Management consulting services.
- We develop customized training plans with the purpose of installing the best skills within your work team.
- We promote the triple helix model of innovation by intervening in the interactions between the knowledge area, industry and the public sector.
- Knowledge transfer, building sustainable capabilities within the organization
We offer you a free CAPA (Corrective and Preventive Action)
Plan template to organize the activities within your organization.
Cooperation in professional training and development of customized plans for the client.
Connection with other training organizations.
Diagnosis and assessment of the level of compliance with Good Manufacturing Practices (GMP)
Identification of opportunities, design and follow up of improvement plans for GMP, GLP, GXP compliance.
Equipment suppliers, Science and Technology (S&T) services and institutions for research and innovation (R&D&i).
Support in the development of productive processes and/or innovative methodologies and technologies.
Promotion of strategic partnerships.
Development and implementation of internal and external audits, CAPA plans, Management of Nonconformities, OOS, Root Cause Analysis, Risk Assessment, Quality Indicators, Exchange Control, etc.
Drafting, review and implementation of Operating Procedures, Excel and Register Spreadsheets. Filing system and information management.
Design, development and Implementation of Validation Master Plan (VPM), Protocols and Reports of: Validation of Manufacturing Processes, including Biological processes, Cleaning Validation, Aseptic Packaging and Qualification of Clean Areas, Equipment and Critical Services, Cold Chain. Computer System Validation (CSV).
Design, development and implementation of the Risk Management program. Drafting of related documentation.
Specific training courses about the use and implementation of risk assessments tools.
Holistic and cross-functional review of all documentation: regulatory affairs, development, quality control and production, to achieve consistent, organized, and accurate information, thus avoiding delays in the launch
Production, Warehouse and Logistics, Quality Control, Regulatory Affairs, Purchasing.
Review and drafting of procedures, training courses, development of effective and efficient processes.
Review and update of documentation for the Registration Dossier of pharmaceuticals, veterinary Products, cosmetics, and medical devices, at the local, regional, and highly regulated country levels. Common Technical Document (CTD).
We are Guadalupe Castillo, pharmacist and Paula Marotta, biochemist and pharmacist, we went to College together and nowadays we are business partners at
TH asesores. Over the last 15 years, we have been have held key positions in national and multinational industries, both in the public and private sectors, and we have been actively involved in academic tasks.
We have extensive experience in the implementation of Quality Management Systems (QMS) and in team training.
We have the expertise to support your company in maximizing every project and exceeding future goals.
We believe that the growth of an organization is a continuous development, which demands introspection, observing its own mistakes to learn from them.
