We provide pharmaceutical companies and drugstores with CTD (Common Technical Dossier) Filing, review of regulatory files for the purpose of registration or re-registration in accordance to CTD requirements, e-submission (eCTD) support, response regulatory authorities for deficiency letters, and stability study review and justification.
- We can help in the development of new products, including pharmaceuticals, medical devices, supplements, cosmetics, and personal care products.
- We also help to resolve troubleshooting during the product development stage or in accordance with post-approval changes regulations.
- Pharmaceutical expert reports, clinical and non-clinical.
- Pharmacokinetics and bio-waiver reports.
- Cosmetic product safety reports.
- 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 reports, PSUR development, a 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:
- A 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 includes pre-formulation & 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 files, and Safety Reports.
- Manufacturing sites auditing: According to GMP requirement and ISO 22716