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Services

Regulatory Services

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

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.

Reporting

  • Pharmaceutical expert reports, clinical and non-clinical.
  • Pharmacokinetics and bio-waiver reports.
  • Cosmetic product safety reports.

Pharmacovigilance Services

  • 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