Regulatory Affairs, Compliance and Dossier development

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

• Evaluation of EU dossier
• Reviewing, writing, adapting and annotating of product information (SmPC, PIL, packaging texts)
• Preparation application forms and cover letter
• eCTD publishing / submission
• Regulatory activities until Marketing Authorisation (MA) decision
• Regulatory consulting
• MA holding

• 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

• 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
• 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.

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