Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

Regulatory Affairs, Compliance and Dossier development

With a well-established local presence in each region of the world and a thorough understanding of regulatory requirements, we are able to ease the task of compliance in this complex regulated industry.

1,500+
product registrations
600+
life cycle management projects
12
scientific advice meetings
5
referrals

European Economic Area

Regulatory Services – European marketing authorisation application (MAA) and life cycle management (LCM)

ELC’s services include the following:

Pre-Submission

  • Regulatory due diligence and strategy
  • Scientific advice meeting
  • MAA dossier – full modules preparation
  • Dossier – due diligence and baseline preparation
  • Product information preparation – SPC, PIL and labelling, eCTD publication services
  • Liaison with EU agencies for pre-submission activities such as slot booking, scientific advice etc.
  • Support for local requirements (e.g. local representative, preparation of locally required documentation)

Submission

  • Submission of applications via European and national portals, as required
  • Liaison with EU agencies throughout the assessment period
  • Deficiencies management
  • Local regulatory support/local representatives in EU
  • Translation of product information text (and harmonisation for generics)
  • DTP services i.e. mock-ups preparation and updates

After Approval

  • Lifecycle maintenance: variations (Type IA, IB, II), renewal, and MA transfer, ‘sunset clause’ exemptions package, withdrawal
  • Dossier consolidation
  • MA duplication procedure
  • Pricing and reimbursement
  • Certificate of Pharmaceutical Product (CPP) issuance and legalisation

USA

  • Pre-submission activities such as controlled correspondences, meeting requests: Pre-IND, EOP1, EOP2, Pre-NDA/Pre-BLA/Pre-ANDA meetings
  • Gap analysis of documents to be filed and dossier preparation
  • Preparation of regulatory strategy report for US FDA submission
  • Preparation, review and submission of INDs, NDAs, 505(b)(2) applications
  • Preparation, review and submission of ANDAs in line with refuse to receive (RTR) and GDUFA II requirements
  • Submission activities such as M1 and Chemistry, Manufacturing and Controls (CMC) compilation, eCTD publishing and deficiency responses to FDA
  • Post approval changes which involves the evaluation of proposed changes, defining the submission category, regulatory assessment of supporting documents along with compilation, review and submission of supplements/amendments packages to FDA.
  • Other US administrative services such as establishment registration and drug listing, and request for pre-assigned submission number, FEI number, NDC labeller code and D-U-N-S number
  • Life cycle management activities such as transfer of ownership applications, PADER/PBRER submission, compilation, review and submission of Prior Approval Supplements (PAS), Changes Being Effected (CBE-0), Changes Being Effected – 30 (CBE-30) and annual reports.
  • Preparation of labelling for human prescription drug label, OTC and biological license applications (BLAs)
  • Preparation of package leaflet in SPL, labelling review and compliance
  • Support in routing of submission through FDA ESG portal
  • US agent services

Russia and Commonwealth of Independent States (CIS) countries

Registration of medicinal products and medical devices in Russia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Armenia, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan, Georgia and Ukraine and CIS countries/classification of medical devices and obtaining the CE Mark in Russia and CIS countries

  • Medicines and APIs registration on “turnkey” basis (full range of services)
  • Variations of all the types preparation, submission and follow up till the final approval
  • MDs registration
  • Regulatory and GMP trainings depending on the company’s needs
  • GMP pre-audits, documents submission and follow up, support of GMP audits from Russian authorities.

Rest of the world (emerging markets: China, ASEAN, LATAM, etc.)

  • Marketing intelligence report/local regulation intelligence and support
  • Gap analysis/due-diligence dossier
  • Full dossier preparation
  • National submission
  • Regulatory training