Regulatory Services

REGULATORY STRATEGY

Development of the appropriate regulatory strategies that:

  • Lead to a more predictable product development process
  • Bring new products to the market faster
  • Meet your business goals
  • Maximize your progress toward success
  • Reduce your risk of failure
  • Help you respond quickly to the changing regulatory environment

 

PRE-MARKETING ACTIVITIES

  • IND, CTA, IB, IMPD, IDE and PIP
  • NDA, ANDA, BLA, MAA, CE Marking, 510(K) and PMA
  • Fast track applications
  • Orphan drugs application
  • Annual report production
  • Medical writing
  • Regulatory project management
  • CMC writing and compilation
  • FDA and other health authorities meeting preparation

POST-MARKETING ACTIVITIES

  • NDA, ANDA, BLA, MAA, 510(K), PMA and design dossiers amendments
  • License renewals
  • Line extensions
  • Annual report production
  • Post-approval commitments monitoring
  • Advertising and promotional material review and approval

 

 

REGULATORY OPERATIONS AND PUBLISHING

  • Submission-ready documents creation
  • Dossier lifecycle management and version control
  • Thorough QA/QC of submission's dossier
  • eCTD compilation and submission
  • CSR publishing
  • eCTD XML backbone creation
  • SPL and PLR labeling conversion
  • esubmmission to FDA and Health Canada via gateway

 

QUALITY

GAP ANALYSIS AUDITS

Routine quality audits performed on regular basis as required by quality system regulation

 

QUALITY SYSTEM AUDITS

Audit performed against FDA CFR 820 and ISO 13485 as preparation for FDA quality system inspections and ISO 13485 certification by notified bodies

 

 

GMP AUDITS

Audits performed against FDA 21 CFR 211 as preparation for FDA current GMP inspections

 

DUE DILIGENCE AUDITS

Audits performed against predefined standards to identify non-compliances before acquisition, merger or licensing agreement

 

SAFETY

PRE-MARKETING SAFETY

  • Receipt, data entry, review, analysis, coding and follow-up on serious adverse events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSAR) from clinical studies
  • Safety input to protocols, clinical study reports and investigator brochures
  • Safety data reporting to competent authorities, ethics committees and investigators

 

 

POST-MARKETING SAFETY

  • Complaints collection, evaluation and review
  • Medical safety assessment of individual case reports
  • Adverse events reporting to health authorities
  • MedWatch 3500A reports completion and submission
  • PSUR preparation and submission
  • Medical literature screening
  • Health authority PV databases monitoring
  • Products safety profile building and continuous updating