Deren Pharma regulatory affairs team provides our customers with full support for regulatory product development, regulatory submissions, follow-ups for approvals and life-cycle management. Our experts evaluate client’s products, current status of their facilities and provide insightful solutions for potential regulatory hurdles. Our aim is to ensure the quality of submissions to worldwide agencies to maximize the likelihood of successful review.

 

 

US – Regulatory Affairs

 

Regulatory Agent

 

Deren Pharma can be your designated US Agent to represent your company in USFDA and other govt. agencies for your regulatory submissions and follow-ups, both pre-approval and post-approval.

 

Regulatory Submissions

 

Deren Pharma provides expert advice and regulatory support for submissions and follow-ups. We help you with:

 

  • Regulatory Guidance during Product Development.
  • Regulatory Guidance and Support during Scale­Up and Technology Transfer.
  • ANDA Preparation – Module­1 to Module­5: Scientific writing as per the USFDA guidelines.
  • Draft Labeling Preparation and Art­works Review before submission.
  • Dossier Review, Gap analysis and suggesting corrective actions before Submissions.
  • Dossier conversion to eCTD.
  • Support in Electronic submissions to USFDA through ESG Gateway.
  • Preparation of Responses to Queries from USFDA.
  • Review of your prepared Responses to Queries to ANDAs.
  • Preparation and/or submission of Annual Reports.
  • Preparation and/or submission of Supplements to ANDAs (Post Approval Amendment (PAS) and CBE 30 application).
  • Regulatory Follow up with USFDA for Approvals.
  • Labeler Code Registrations.
  • Obtain DUNS number.
  • Drug Firm Establishment Registration with US-FDA.
  • Obtain FEI No. [Federal Employer Identification Number].
  • Support in Self Identification of the Company and GDUFA fees payment.
  • Drug Listing in SPL [Structured Product labeling] format, Bulk Drug Listing.
  • Preparation, Review and Submission of DMF [Drug Master Files], Amendments and Annual updates.
  • Assistance for preparation and/or Review of Responses to 483s and Warning Letters.

 

 

 

 

EU – Regulatory Affairs

 

Deren Pharma provides expert advice and regulatory support for submissions and follow-up with Regulatory Authority of each country.

 

Regulatory Submissions

 

We help you with:

 

  • Dossier Preparation: Module­1 to Module­5 Scientific writing as per the EU guidance.
  • MAA Review, gap analysis and suggesting corrective actions before Submissions.
  • Dossier conversion to eCTD.
  • Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet and Product rationale
    • Expert Report on Quality.
  • Overviews (Module 2),

– Clinical.

– Non-Clinical.

  • Nonclinical Study Reports (Module 4).
  • Clinical Study Reports (Module 5).
  • Regulatory Submissions through DCP, MRP and National procedure.
  • DCP slot booking.
  • Preparation and Review of Renewal applications.
  • Preparation and Review of Variation Applications.

 

Readability Testing for Leaflets

We provide services for Patient Information Leaflet Readability Testing which is a mandatory part of a human medicinal product marketing authorization.

 

Batch Release services in EU

 

We also assist our clients with,

  • QP services for batch release in EU markets.
  • GMP certified QC laboratories within EU.

 

Emerging Markets – Regulatory Affairs

 

Deren Pharma provides expert advice and regulatory support for regulatory submissions, follow-up for approvals and approval road map for each country. We help you with:

.

  • Regulatory input for various emerging markets.
  • Preparation, Review and Submission of Registration dossiers in CTD/eCTD (Electronic Common Technical Document) and ACTD [Asian Common Technical Dossier].
  • Preparation and Review of Response to Queries from Regulatory Authorities on Dossiers.
  • Preparation and Review of Responses to Points raised during Regulatory authority Audits.
  • Preparation of Gap Analysis reports.
  • Follow-ups with Regulatory Authorities for Registration.