We provide pharmaceutical companies with CTD Filing, Reviewing, and e-submission (eCTD) support.
Several training courses for the pharmaceutical professionals in Method of Analysis Development, Analytical Methods Validation, Technical Aspects of the Pharmaceutical Industry and Regulatory Affairs, Cleaning Validation for Cosmetics and Medical Device Manufacturers, and ISO 17025. Find out more about our training programs.
- Pharmacovigilance System Setup: Set up a comprehensive pharmacovigilance system that complies with the relevant regulatory authorities requirements. The system will include approved procedures for adverse drug reaction report, PSUR development, qualified person for pharmacovigilance (job description), training, and reporting. In addition, staff training on how to implement and maintain the pharmacovigilance system.
- PSUR Reporting: Preparation of PSURs that review scientific literature and evaluate the company's data individually and prepare complete and ready to submit PSURs for human medicinal products. The PSUR reporting service includes:
- Thorough review of scientific literature in medical sources
- Review, evaluation, and processing of suspected adverse drug effects (ADRs)
- Analysis of company-specific data
- Preparation of a customized periodic safety update report (PSUR)
Sites Inspection and Qualification
We provide auditing and certification service to help manufacturers of health care products comply with the safety and quality regulations:
- Gap analysis for pharmaceuticals or Cosmetics sites versus GMP requirements, including Quality Management System (QMS), SOPs and their implementation.
- Gap analysis for analytical labs versus ISO 17025 requirements, including quality system, SOPs
- Pre-inspection audits for sites or labs expecting regulatory inspection.
- Upgrading cosmetic manufacturing facilities for registration at the Ministry of Health for manufacturing General Sales List Products (GSL)
- Upgrading manufacturing facilities to comply with ISO 13485.
- Support in Site Master File (SMF) preparation
- Support in specific Standard Operation Procedures (SOP’s) preparation
Testing Laboratories Support
ISO/IEC 17025:2005 is the standard for the accreditation of testing and calibration laboratories. We can help develop an internal management system under this standard through the following phases:
- Phase I : Site assessment and gap analysis: A site assessment will be conducted to evaluate the level of compliance to ISO 17205 requirements, and a detailed report with modifications required, responsible personnel for modifications and time frame for implementation.
- Phase II: System development: Determining the management and technical requirements, developing Quality Manual, and developing Quality SOPs for ISO 17025 compliance.
- Phase III: System Training and Handover: At the end of this phase, your staff will be ready to implement and maintain the approved quality system.
- Phase IV: Preparing for accreditation inspection: Our team will conduct an independent audit as a mock accreditation audit to make sure of your preparedness to the official accreditation inspection from the accreditation bodies.
Cosmetics Manufacturers Support
- Product development: From the initial premature idea till market launch, which include preformulation & formulation studies, product evaluation, claims setting and regulatory services.
- Evaluation of borderline products: This falls between cosmetics, medicinal products and medical devices, and setting the proper wording of claims and labeling.
- Regulatory affairs support: Including preparation of product information file, and Safety Reports.
- Manufacturing sites auditing: According to GMP requirement and ISO 22716