KMS Pharma Provide regulatory support in drafting dossiers for various geographies per CTD format electronically and run validation. Document collation, technical writing and drafting response to queries are handled by team. KMS Pharma have experience in compilation of sections of ANDA and EU dossiers are done at KMS Pharma for filing. Following services can be offered.
Elaboration and evaluation of drug substance and Drug Master Files (ASMF & DMF),.
Quality Overall Summary (QOS) and Certificates of Suitability (CEP).
Escort of registration procedures (MRP, DCP and ANDA).
Regulatory strategy development and implementation.
Regulatory submission oversight, management, preparation, maintenance, and quality assurance.
Regulatory authority interactions, including serving as US Agent.
Regulatory compliance gap analysis and issue resolution.
Scientific, regulatory, and due diligence reviews of regulatory documents and submissions.
Regulatory and scientific document development, preparation, and quality assurance.