Drug registration

Smooth Drug Development offers services in drug registration.
State registration is a key step in drug’s development process. The outcomes of drug evaluation and decision on state registration may vary depending on the initial goals of the drug development, pre-clinical and clinical trials’ planning.
Our specialists offer the following services:
Gap-analysis of you registration dossier as well as registration strategy development
  • Completeness check and registration dossier analysis
  • Registration roadmap development
  • Consulting on drug registration in the following countries:
    • Russia
    • Belorussia
    • Kazakhstan
    • Armenia
    • Kirgizia
    • Georgia
    • Ukraine
    • EU
    • India
    • Brazil
    • Jordan
    • Malaysia
    • Pakistan
Translation of documents
  • Professional translation of the documents and registration dossier materials from English to Russian or vise-versa
Normative Documentation development
  • Compilation of the list of pharmaceutical quality indicators and development of the analytical methods for it’s measurement in accordance with Federal State Budgetary Institution (FSBI) of Ministry of Health (Russia) “National Research Center for Medicinal Products Quality Control” (NRCMPQC) requirements
  • Drug and pharmaceutical substance specification file project development
  • Existing specification file adjustment in accordance with FSBI of Ministry of Health (Russia) NRCMPQC requirements
  • Assistance in preparation of responses to the comments from experts of FSBI of Ministry of Health (Russia) NRCMPQC’s
  • Consulting on the development and validation of quality control methods for inclusion in specification file
  • Quality control methods approbation in independent laboratories (centers), accredited by ISO / IEC 17025
  • Further development of analytical methods in case of its non-reproducibility
Product’s package layouts preparation
  • Technical specification of product’s package layout preparation in accordance with an art. 46 Of Federal law "On circulation of medicines" N 61-FZ
  • Preparation of primary and secondary (consumer) product’s layouts
Patient information leaflets (PILs) preparation
  • Preparation/adjustment of PIL in accordance with the Ministry of Health (Russia) requirements
  • Coordination of the GMP inspection by the Industry and Trade Ministry of the Russian Federation
  • Application for the GMP inspection of the Industry and Trade Ministry of the Russian Federation
  • Inspections’ schedule approval
  • Support in preparation to the inspection
Registration dossier preparation
  • Registration dossier preparation based on the CTD format, with the possibility of further drug registration in a list of countries
  • Preparation of Module 3: "Quality" (section of chemical, pharmaceutical and biological documentation), in accordance with the requirements of ICH M4Q (R1) and the Ministry of Health (Russia)
  • Adjustments of existing Module 3: "Quality" to the requirements of the Ministry of Health (Russia)
  • Preparation of Section 2.3: "Quality Overall Summary" – QOS of CTD’s module 2 in accordance with the requirements of ICH M4Q (R1)
Registration dossier submission
  • Dossier submission to the Regulatory authorities
  • Queries resolution
  • Consulting on the received queries
Preparation of the application to the WHO for INN and ATC code assigning
  • Preparation of the application to the WHO for INN of a pharmaceutical substance assigning
  • Preparation of the application to WHO for a ATC code assigning
  • Application status monitoring and approval notification of the applicant
State registration of pharmaceutical for human use confirmation
  • Confirmation of the drug’s state registration preparation and submission
Patient information leaflets change
  • Preparation of amendments to PILs and submission of the application
Our specialists have a great experience in registration of both innovative and generic drugs with either chemical or biological origin. We are ready to provide a high-skilled support in any step of registration process.
Smooth Drug Development offers support in drugs’ registration process since 2013.