Regulatory Affairs

Regulatory Operations

Helping you navigate the ever changing global environmental

Our highly experienced team of regulatory affairs professionals deliver complete regulatory submission services to our clients. We help guide and support you to meet regulatory requirements throughout the different stages of drug development and post approval. Our worldwide regulatory experience spans across regulated markets (US, EU, Canada, Australia, NZ) as well as emerging markets (e.g., Latin America, Africa, Asia, CIS, and Middle East).

Pre-Approval Submissions Services:

  • Plan and develop global submissions
  • Ensure data generated to support an application meets regulatory requirements
  • Lead client’s cross-functional teams to plan and coordinate the documents needed to support regulatory applications in CTD, e-CTD or NeeS format like –
  • USDMF, EDMF, COS/CEP for Drug substance
  • Investigational New Drug Application (IND)
  • Investigational Medicinal Product Dossier (IMPD)
  • Clinical Trial Application (CTA)
  • New Drug Application (NDA)
  • Biologics License Application (BLA)
  • Abbreviated New Drug Application (ANDA)
  • Marketing Authorization Application (MAA) for regulated and emerging markets
  • Global label development:
  • Artwork Preparation (label, secondary packaging like carton, foil, package insert, etc.)
  • Structured Product Labeling (SPL)
  • Labeling updates and amendments
  • Product Information Leaflets (PIL)/Medication guide
  • Country specific conversion of Labeling
  • Company Core Data Sheet (CCDS) and Labelling Justification Document (LJD) authoring

Product Life Cycle Management (PLM) includes the entire lifecycle of a product from its conception through obsolescence. Products which have been put on the market change over time and must be managed as it moves through its succession of stages.

Our highly experienced regulatory affairs professionals are well versed with the requirements for the product life cycle management.

Post-approval regulatory support activities:

  • Submission of supplements, amendments and variations applications
  • Annual reports (labeling, stability, distribution and CMC changes)
  • License renewal applications
  • Regulatory compliance reviews checking approved license information against technical documents used in manufacturing and testing of medicinal products
  • Maintenance of labels and reference safety information
  • Review and approval of advertising/promotional materials
  • Drug Master File (DMF) updates