Pharmaceuticals and other medicinal products need to be prior authorized by the regulatory authorities of the market/region they want to be sold in. Each market/region has a different framework and distinct guidelines for the review and assessment of pharmaceuticals. Each framework is unique therefore it is difficult for regulatory departments and organizations to implement authorization requirements and procedures without any errors. As a result, the timeline for the processes involved in evaluating a new product is extended. Additionally, requirements imposed by individual countries/regions, and the many guidelines and regulations from global organizations such as ICH and WHO can make the processes lengthier. Thus, the regulatory requirements and procedures for marketing authorizations of new products in various countries is quite diverse. Understanding these different regulations, developing a plan that adheres to the guidelines set by global authorities such as ICH and WHO makes it an exhaustive, complex process.
DDReg has been providing high-quality regulatory services for over a decade. Here our expert team is highly experienced and knowledgeable, with extensive experience in pharmaceutical regulatory consulting. Filing new product authorization applications to more than 100 countries and responding to respective queries has been an enriching experience for DDReg.
We offer pre-submission technical data reviews, Gap Analysis, Regulatory Content authoring, Dossier compilation, validation, and electronic publishing of new product authorization applications for global filing. We also offer end-to-end New Product Authorization advisory as well as hands on services to pharmaceutical organizations that include
Following are the services and activities provided by DDReg:
- Reviews on product dossiers/technical documentation
- Gap Analysis & Remediation Advisory
- CTD Authoring - CMC Sections, Non-Clinical & Clinical Overviews & Summaries
- Biowaiver Justifications
- Run procedures – MRP/DCP/CP/RUP in EU, WHO PQ,
- SmPC/PIL/PI authoring and/or Reviews
- Artwork reviews
- Agency Query responses
A remediation strategy is developed and tailored according to the customer’s requirements once all gaps have been identified.