Our objective is to listen and understand YOUR business needs in order to provide YOU with the right regulatory solutions
Pharmaceutical, Medical Device & Cosmetic Products
YOU will be sure that we will be getting the right help YOU need to carry out YOUR business Regulatory tasks
Pharmacovigilance Services
- Local QPPV Services appointment in targeted MENA country
- SOP & Pharmacovigilance System Development
- MLM (Medical Literature Monitoring )
- Pharmacovigilance Quality Management: Establishing quality management systems to ensure that pharmacovigilance processes are conducted effectively and efficiently.
- Aggregate Safety Reporting: Preparing and submitting periodic safety update reports to regulatory authorities summarizing the safety profile of the pharmaceutical product.
- Pharmacovigilance Inspections and Audits: Conducting inspections and audits to ensure compliance with pharmacovigilance regulations and guidelines.
- Risk Management Planning: Developing risk management plans to minimize identified risks and ensure the safe use of pharmaceutical products
Pharmaceutical, Medical Devices , and Cosmeceuticals Regulatory Services
- Pharmaceutical, Medical Device, Cosmeceuticals Product Approval and Registration Support: Providing guidance and support throughout the product approval, registration process and renewal, including compiling and submitting regulatory dossiers to health authorities.
- Regulatory Submissions Management: Managing and coordinating all aspects of regulatory submissions to health authorities, including Investigational New Product Applications and New Product Applications.
- Post-Marketing Regulatory Affairs: Assisting with post-approval regulatory activities, such as variations, renewals, and updates to approved drug, medical device & Cosmeceuticals applications.
- Labeling and Packaging Compliance: Helping pharmaceutical, Medical Device, and Cosmeceuticals companies create and review product labeling and packaging materials to ensure compliance with regulatory requirements.
- Regulatory Training and Workshops: Conducting training sessions and workshops for pharmaceutical, Medical Device and Cosmeceuticals company staff to enhance their understanding of regulatory processes and compliance.
- Quality Management Systems (QMS) Support: Assisting in the development and implementation of effective Quality Management Systems to meet regulatory standards.
- Clinical Trial Application Support: Assisting with the preparation and submission of clinical trial applications to regulatory agencies, ensuring compliance with local regulations and international standards.
- Regulatory Intelligence: Monitoring and providing updates on changes in pharmaceutical, Medical Device and Cosmeceuticals regulations, guidelines, and requirements to keep clients informed and compliant.
- Regulatory Advocacy: Representing clients and advocating for their interests in interactions with regulatory authorities.
Regulatory Compliance Audits Support Services
- GMP Compliance: Ensuring compliance with Good Manufacturing Practice (GMP) regulations, which dictate the quality standards for the manufacturing and testing of pharmaceutical products.
- Regulatory Reporting Compliance: Verifying compliance with requirements for reporting information to regulatory authorities, such as product changes
- Pharmacovigilance: Evaluating compliance with pharmacovigilance regulations, including the proper reporting and management of adverse events associated with pharmaceutical products.
- Pharmaceutical Storage and Distribution Compliance: Ensuring that pharmaceutical products are packaged, stored, and distributed in compliance with regulatory guidelines.
- Controlled Substances Compliance: Assessing compliance with regulations for handling and distributing controlled substances used in pharmaceutical products.
- Labeling and Packaging Compliance: Ensuring that drug labeling and packaging meet the necessary regulatory standards for accurate information and safety.
- Advertising and Promotion Compliance: Verifying compliance with regulations related to pharmaceutical product advertising and promotional materials to prevent misleading claims.
- Clinical Trial Compliance: Verifying compliance with Good Clinical Practice (GCP) guidelines during the conduct of clinical trials, ensuring patient safety and data integrity.
- Data Integrity: Assessing compliance with data integrity requirements to ensure the accuracy, completeness, and reliability of data generated during various processes.