Regulatory Services:
Our regulatory experts compile the dossiers (DMF, ASMF, APIMF, CEP, ANDAs, NDAs, Scientific advice, PIND and INDs), in CTD/ACTD/NeeS format as per country specific requirement for international, ROW and other markets. Experts help the companies in addressing the deficiencies of regulatory agencies if requested during review of application.
We are expert in the following
- Dossier drafting and compilation (ANDA/NDA/MAA writing and submissions)
- DMF drafting and compilation (DMF/ASMF/CEP writing and submissions)
- IND/IMPD writing and submissions
- Regulatory agency meetings (Type A, B and C)
- Scientific advice and Briefing packages writing
- Post marketing strategy
- Life cycle management
- Regulatory support w.r.t documents review and Due diligence
- Query handling received from Regulatory Agencies and customer
- Artwork management
GMP Audits and compliance:
Audits are a vital component of supplier qualification, regardless of the services or products sourced.
IKReg GMP experts conduct independent, competent audits worldwide, ensuring compliance with accepted standards and current legal requirements. This service is available to all participants across the supply chain, providing comprehensive support for maintaining regulatory excellence.
GAP Analysis:
Gap analysis is used by all the pharmaceutical companies to analyze processes of any division of their company. In this process, we follow all the guidelines of all current practices and make a review for adequacy, suitability, effectiveness, compliance. IKReg help to the pharma industries to identify all the Gaps and also help to find which process need to be fixed like quality management process, internal communications process, document control process, record keeping process, training process, internal audit process, management review process, measuring and monitoring process and continual improvement process.
Due-diligence:
Gap analysis of the legacy dossiers against current practices followed in the manufacture of the medicinal products
Vendor qualification:
Our team provides complete support and solution to our client’s need for sourcing of pharmaceutical materials considering needs of regulatory compliance of manufacturing sites.
Pharmacovigilance:
Our team delivers comprehensive pharmacovigilance services (PSUR & DSUR) to ensure the safety and efficacy of healthcare products. The risk assessment to regulatory reporting and compliance, we provide end-to-end solutions tailored to meet the needs of our clients. With a focus on patient safety and adherence to global regulatory standards, IKReg is your trusted partner in managing drug safety across the product lifecycle.