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.
Product Development Services
- 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