At Qualipharma, we offer a comprehensive consulting service specialized in GxP, FDA, and ISO 13485 regulations, supporting your project from conception to final approval. We focus on ensuring that each phase complies with applicable regulations to guarantee the global commercialization of your products.
We offer you our consulting service with a comprehensive approach that includes process evaluation, internal audits, implementation of compliance programs, and training for work teams. Our expertise allows us to identify risks, optimize procedures, and strengthen the quality system.
Regulatory Compliance Consulting We offer expert consulting for compliance with GMP, GDP, GCP, GLP, and GVP regulations, aiming to ensure that your company meets the highest regulatory standards, optimizes processes, mitigates risks, and ensures the quality and safety of its products.
Regulatory Compliance Audits and Audit Simulation We conduct regulatory compliance audits and internal audit simulations to assess the state of the quality system, identify gaps, and ensure readiness for inspections by agencies such as FDA, EMA, ANVISA, and COFEPRIS, ensuring regulatory compliance and continuous improvement.
Support in Regulatory Inspections: FDA, EMA, ANVISA, COFEPRIS We provide comprehensive support in regulatory inspections from organizations such as FDA, EMA, ANVISA, COFEPRIS, among others, ensuring team preparation, document review, management of findings, and the implementation of action plans (CAPA Plan) to ensure regulatory compliance.
CAPA Management Remediation We implement effective remediation strategies and CAPA (Corrective and Preventive Actions) management to identify, correct, and prevent deficiencies in processes, ensuring regulatory compliance, continuous improvement, and optimization of the quality system.
Outsourcing of quality and compliance roles: QP, QA, QC, RP (embedded consultant) We provide outsourcing for key roles in quality and compliance (QP, QA, QC, RP) to ensure operational continuity, regulatory compliance, and excellence in quality processes.
Good Distribution Practices (GDP) Certification We offer expert consulting for the proper distribution of human and veterinary medicines. We focus on compliance with GDP regulations, providing tailored solutions at each stage of the distribution chain, from the warehouse to pharmacies and hospitals receiving the medication, ensuring integrity throughout the entire supply chain.
Marketing Authorization Holder (MAHs)– Pharmaceutical Distributor
Transport Route Validation
We conduct a risk analysis of the transport routes used to identify the most critical ones and carry out route validation in accordance with GDP regulations, ensuring that medicines arrive in optimal conditions at their destination.
Quality Management in Technology Transfer Projects We ensure comprehensive quality management in technology transfer projects, guaranteeing regulatory compliance, process validation, and the harmonization of quality standards at each stage of the project.
Quality Management Support in International Projects This service focuses on ensuring compliance with global regulations and the integration of quality systems in international projects within the pharmaceutical, biotechnology, and medical device industries. We provide support to facilitate the harmonization of activities in companies operating in multiple countries or developing products and services in markets regulated by different entities.
Specialized Training Certify your talent in the industry at Pharmaceutical Quality System and Compliance with our catalog of courses in both in-person and online formats. Discover e-learning by Qualipharma
We implement and maintain robust quality systems to ensure regulatory compliance in the pharmaceutical industry, thus ensuring the safety, quality and efficacy of medicinal products. Our consulting service provides specialized solutions for the design, optimization, and continuous improvement of processes that strengthen quality at all stages of the supply chain. Our approach minimizes risks, enhances traceability, and optimizes operational efficiency.
Development, Implementation, and Improvement of Quality System Development and implementation of quality documentation (SOPs, policies, quality manuals) for a newly created department or from an existing quality system to make it more efficient and robust.
Quality System Maintenance Change Control Management.
Management of deviations, complaints, and non-conformities.
Development of the PQR Report, statistical data analysis.
Quality Risk Management (QRM) Application of ICH Q9 – Quality Risk Management (QRM).
Implementation of methodologies such as FMEA (Failure Modes and Effects Analysis), HACCP, HAZOP, Ishikawa.
Risk management in manufacturing processes, validation, and supply chain.
Risk assessment in Data Integrity and computerized systems.
Risk-based approach in change management and validations.
Process, Cleaning, and Analytical Method Validation Cleaning Validation and Control
Analytical Method Validation
Process Validation
Implementation of Annex 1 The update to Annex 1 involves significant changes that affect both operational procedures and the infrastructure of sterile drug manufacturing facilities. At Qualipharma, we help you assess the impact on your laboratory and implement the necessary updates.
Cross-Contamination and Containment Cross-Contamination Risk Assessment and Risk Management
Design and Validation of Containment Systems.
Environmental Monitoring and Control
Material and Production Flow Management
Microbiology Support Specialized Training We have a team of auditors with experience and certified training, who stay up to date with regulatory changes. This allows us to carry out audits in accordance with current regulations and considering any anticipated changes.
Supplier Certification We ensure that suppliers comply with the regulatory, quality, and safety requirements established by the pharmaceutical industry and regulatory agencies.
Good Manufacturing Practices - GMP We ensure compliance with good manufacturing practices at all stages of the lifecycle of a medicinal or healthcare products. Our audits verify that companies adhere to international regulations to ensure the safety, quality, efficacy, and data integrity in the manufacturing, distribution, and monitoring of pharmaceutical products.
We conduct audits in accordance with GMP standards from EMA, FDA, MHRA, TGA, ANVISA, INVIMA, COFEPRIS, etc.
Medicinal Products
Good Distribution Practices - GDP Compliance with the requirements for the storage, transportation, and distribution of medicinal products and active substances to ensure their quality and integrity throughout the supply chain. We conduct audits in accordance with the Good Distribution Practices (GDP) for Medicinal Products for Human Use – Directive 2013/C 343/01 – Regulation EU 2021/1248 (for API imports) – WHO: Guidelines on Good Distribution Practices for Pharmaceutical Products – FDA 21 CFR Part 205 – ICH Q7.
Good Laboratory Practices - GLP These audits aim to ensure the quality and integrity of the data generated in laboratory studies to guarantee the reliability of the results. We conduct audits in accordance with the OECD Principles of Good Laboratory Practice, FDA 21 CFR Part 58, and WHO guidelines.
Good Pharmacovigilance Practices - GVP Evaluation of compliance with pharmacovigilance procedures to ensure the safety of medicines on the market. We conduct audits in accordance with EMA Good Pharmacovigilance Practices, FDA 21 CFR Part 314.80 and 314.81, ICH E2E, WHO, Directive 2010/84/EU, and Regulation 1235/2010.
Technological Compliance and Data Integrity We evaluate the level of compliance in pharmaceutical processes, ensuring that the information generated and stored is reliable, accurate, and secure, based on the following regulations and international standards: 21 CFR Part 11 – EU GMP Annex 11 – Cybersecurity in Regulatory Systems (FDA, EMA, GAMP 5) – Validation of Document Management Systems (DMS, Electronic QMS) – Compliance with Data Integrity (ALCOA+, FDA, EMA, WHO).
Regulatory Assessment We ensure compliance with the applicable regulations and standards for the authorization, marketing, and monitoring of medicines, medical devices, and other healthcare products. We conduct audits in accordance with ICH Q8, Q9, Q10, ICH E6 (GCP) – WHO – ISO 13485 – ISO 14155 – PIC/S – Regulatory GMP guidelines – 21 CFR Part 314 – 21 CFR Part 600-680 – Directive 2001/83/EC – EudraLex Volume 4 – ANVISA, INVIMA, ISP.
Specialized Training Certify your talent in the industry at Pharmaceutical Quality System and Compliance with our catalog of courses in both in-person and online formats. Discover e-learning by Qualipharma
Tell us what you need, and our team will find the most suitable solution for your project.
Stay up to date with the latest news in the pharmaceutical industry, regulations, and the innovative solutions we offer at Qualipharma.
Designed and developed by BlackBeast | Legal notice | Privacy policy | Cookies policy | Complaints channel