Regulatory and Compliance
Regulatory and Technical Support for Medicinal and Medical device development and new product launch (local or foreign) because of granted authorizations to manufacture (GMP) and commercialize the new product (MA).
Support for renewal and post approval changes of establishment´s and/or product´s authorizations.
Support for Queries management and remediation efforts.
Management of procedures before COFEPRIS.
Regulatory and Technical Support to obtain establishment authorizations from: COFEPRIS, FDA, INVIMA, ANVISA, etc.
Quality Compliance
Support for proper Change Control and CAPA management, Readiness Inspection, Annual Product Review, SOP and Master documents writing or review for further upgrading, as well as SMF management.
Engineering (layouts and flows)
Support to design/refurbish a pharmaceutical establishment, commissioning, Tech-transfer, as well as manufacturing, quality, and supply chain engineering.
Validation
Technical and regulatory support to pursue proper Areas, Critical Systems, Equipment, Manufacturing process, Analytical Method, Cleaning and CSV qualification/validation, as well as CPV and maintenance of validates/qualified state.
Lean Manufacturing and Six Sigma
Support to achieve Process improvement by flow and process mapping/VSM and other tools to led in cost reductions, cycle time reduction, scrap reduction, optimization of inventory management, productivity improvement, etc.
Project Management
New assets implementation, changes in product portfolio, New product Launch, post-approval changes, regulatory conformity, etc.
Personnel Evolution
Support for personnel recruitment, GXP training and tailored made training.
Other
Management of controlled substances.
Vendor’s selection, approval, and management.
Translation Service (EN-SP).
Company Details
- Employees
- 4
- Founded
- -
- Address
- Bruno Traven 162 C204, General Anaya,mexico
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- pharmaclims.com
- Keywords
- Asuntos Regulatorios, Cadena de Suministro, Aseguramiento de Calidad, Validación, Auditorías, Estrategia Regulatoria, FDA, Planeación estratégica, Gestión de proveedores, Sistema de Gestión de la Calidad, Lean Manufacturing, CMC Management, Gestión de Proyectos, Capacitación a la medida, Desarrollo de nuevos negocios.
- HQ
- Benito Juárez, D.F
Pharma Clim Services S.a De C.v Questions
Pharma Clim Services S.A De C.V's website is pharmaclims.com
Pharma Clim Services S.A De C.V's LinkedIn profile is https://mx.linkedin.com/company/pharma-clim-services-s.a-de-c.v
Pharma Clim Services S.A De C.V has
4 employees.
View email and phone details for 4
employees at Pharma Clim Services S.A De C.V.
Pharma Clim Services S.A De C.V's industry is
Pharmaceutical Manufacturing
Pharma Clim Services S.A De C.V's top competitors are
Grupo Grisi,
Laboratorios Grin,
Sophia,
Grupo Collins,
Roche México,
Laboratorios Kener, S.a. De C.v.,
Laboratorios Silanes,
Pisa Farmacéutica,
Megalabs México,
Laboratorios Sanfer.
Pharma Clim Services S.A De C.V's categories are Pharmaceutical Manufacturing
Pharma Clim Services S.A De C.V's founding year is 2014
