International Regulatory Affairs
Regulatory Submissions: A well prepared submission can avoid unnecessary questions and issues during assessment by the Agency. Eclectic provides with highest standards of DMF, dossier submissions for US, EU, Canada, Australia, New Zealand, South Africa and all semi-regulated countries. We deliver dossier submissions in CTD, eCTD and ACTD formats.
Variations:Eclectic believes there is always a bit more documentation to be filed. We provide services for filing of variations (EU), deficiency response, amendments, post approval supplements and annual reporting.
Quality by Design (QbD): Regulated markets are getting competitive day by day. The agencies are keen on enhancing knowledge sharing, reduce cost associated with poor quality (recalls and rejects), improving approval time and minimizing post-approval changes. Eclectic provides support to clients in implementing and filing applications based onQbD.
Product lifecycle management: Product lifecycle management systems are gaining acceptance for managing all information about the corporation’s products throughout their lifecycle, from conceptualisation to operations, regulatory submission to approvals and post approval compliance. Eclectic provides support for product lifecycle management wherein we maintain our information database of product / products assigned to us.
Review: Eclectic understands the latitude to ensure our clients satisfaction. Eclectic provides services for review of pre-filing documents (formulation development and exhibit batches), compiled CTDs, ACTDs and dossiers for all other markets.
Guidance:Eclectic is well informed about the continuous changes and alterations in the Agency’s guidelines and looks forward to provide information and training about the new changes happening across the pharmaceutical world. We provide proper guidance over revisions and additions in the existing regulatory scenario and its impact.
GAP analysis: Eclectic is capable of performing GAP analysis through our enormous experience in audits, systems and procedures followed throughout the pharmaceutical industry.
Labelling and Packaging material development: Regulatory agencies are becoming particularly stricter about the prescribing information provided with a pharmaceutical product. Eclectic provides proper guidance and service for labelling and packaging material development. We also provide translation services for such documents.
For more information please contact us