Regulatory Services

  • Strategy of Regulatory Submission
  • CMC and Manufacturing compliance
  • Dossier Publishing – Electronic Submissions (eCTD or NeeS)
  • Dossier Filing Services
  • Scientific & Medical Writing
  • Life cycle management
  • Readability Testing of PIL and Bridging
  • Gap Analysis
  • Batch Release and Batch Testing
  • Due Diligence of Dossier for ANDA submission

Strategy of Regulatory Submission

For any submission regulatory strategy is very much important. The strategies take into account all the variables of development including (but not exhaustively) IP analysis, costs of developments and registrations, feasibility of submissions, choice of clinical trials, scientific advise and prediction of probable outcomes of registrations.

Our team is expert in clinical, intellectual property, regulatory submission and R&D which gives best suitable advice to enter in regulated or semi-regulated market.

CMC and Manufacturing compliance

We offer below services for global submission;

  • Gap analysis/due diligence and remediation
  • Preparation of technical packages for API for US and EU
  • Type II DMF, ASMF and CEP preparation
  • Writing and compilation of CTD modules 1,2,3,4 & 5
  • Preparation of QbR for US Submissions and quality overall summaries for EU
  • Dossier as per country specific guidelines
  • QP services for batch release and Pre approval inspections
  • GLP/GMP audit
  • MA transfer and related activity

Dossier Filing Services

Marketing authorizations for medicinal products are subject to very strict overall requirements. Preparing, submitting and maintaining CTD/eCTD dossiers places considerable demands on a company’s human resources. We provide complete support of regulatory submission as per country specific requirement. Brief of our services in this segment are listed below;

  • Abbreviated new drug applications (ANDA)
  • Amendments (CBE30, CBE0 and PAS) and annual reports for ANDA
  • Abridge applications for generic products
  • Bibliographic applications
  • MAA for EUROPE submission via National, Mutual Recognition, Centralized and Decentralized Procedures
  • Variations to marketing authorizations (including Type I, IB and Type II variations for marketing authorization updates)
  • Renewal of marketing authorizations in the EUROPE
  • National phase submission package
  • ASEAN country MAA applications
  • Clinical trial applications

Dossier Publishing – Electronic Submissions (eCTD or NeeS)

Common Technical Document (Product Dossier) is an integral Part of any registration application for Marketing Authorization. Dossier in CTD Format/ ACTD Format or local country format is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required technical documents and legal manufacturing permissions.

Considering the recent update in many regulated and non-regulated markets, eCTD is compulsory for new submission and for old submission eCTD baseline submission is also require.

We have developed internal eCTD software NEO-eCTD as well as we also have tie-up with other service provider for country specific requirement.

We provide all services related to this like below;

  • Dossier development
  • Data gap and review
  • NTA to CTD conversions
  • CTD to eCTD conversions as per EU and 21CFR rules for EU and US submission
  • Electronic submissions of Type I, IB and Type II variations
  • Submission package for USFDA submission
  • Structured product labelling (SPL) Publishing
  • Dossier updating
  • DMF dossier compilation
  • Electronic Submissions Gateway available – fastest and safest method for dossier submission in USA

We submit our applications via CESP or other Competent Authority portals to ensure courier costs are maintained as low as possible for you.

Scientific & Medical Writing

We provide a wide variety of scientific and medical writing services, ranging from non-clinical peer-reviewed manuscripts to regulatory submissions and clinical documents.

  • Module 2.4, 2.5, 2.6, 2.7 preparation
  • Preclinical study reports
  • Clinical study reports (Phases I to IV) compliant with
  • Clinical protocols
  • Investigator brochures
  • Investigational Medicinal Product Dossier (IMPD)
  • Informed Consent Forms
  • PSURs
  • Narratives
  • Clinical and non-clinical Expert reports

Life cycle management

Life cycle activity post getting the marketing authorization is important activity to continue smooth supply of product in particular market. Neo has expertise in all aspect related to life cycle activity and can helps in life cycle management of a product in all the countries. Major activities involved in this segment is as below;

  • Evaluation of variation category as per change proposal and regulatory requirement of particular country.
  • Submission management i.e. application form, cover letter and package preparation for Type Iain, Type IA, Type IB and Type II variation submission.
  • Grouping of variation in Europe.
  • Renewal submission as per country specific requirement.
  • PSUR, PBRER submission management.
  • Preparation and submission of changes to approved ANDA in USFDA.
  • All life cycle management submission in NeeS and eCTD format as per country specific requirement.

Readability Testing of PIL and Bridging

Considering directive 2001/83/EC, amended by directive 2004/27/EC and legislations which regulate pharmaceuticals marketing rights extension and renewal, we remind you that it is obligatory to do Package Leaflet (PL) readability testing or to produce bridging reports for all pharmaceuticals.

  • Evaluation of PIL to check if the readability testing is needed or bridging report will be sufficient
  • A thorough review of the text and layout of the product information leaflet (compliance with QRD template according to the procedure – CP, DCP, MRP or national submission – checking of grammar, spelling, clarity)
  • Development of Questionnaire and protocol
  • Screening and recruitment of suitable participants
  • Pilot test performed by an experienced interviewer
  • Further development of the PIL based on the pilot test results
  • Full readability test on 20 participants native in the language
  • Submission of a complete report including all test results

Gap Analysis

We’re here to close the gap. We identify the gaps between your registered details and current ways of manufacturing, record the outcomes and identify the tasks that you need to do, to close this gap. Once we have agreed the remediation strategy with you, we can create the relevant product applications and close that gap efficiently and with ease.

Batch Release and Batch Testing

For commercial supply of pharmaceutical products in Europe, requirement of batch release and batch testing site is quite important. We offer EU GMP approved batch release site and batch testing (Quality control) site in UK and other EU countries as per customer’s requirement.

Due Diligence of Dossier for ANDA submission

ANDA submission is critical in term of acceptance based on USFDA RTR guideline. Hence it is very important for applicant to submit the dossier inline to USFDA guideline of ANDA submission and RTR.

We are having team of regulatory expert who can evaluate the dossier as per USFDA guideline for ADNDA content as well as RTR guideline published as per 21CFR so that the dossier become more acceptable for USFDA submission.

We can provide dossier with PDF property set, hyperlinking and bookmarking as per USFDA requirement. We also can provide eCTD publishing for ANDA submission.