Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
Drug Product Regulatory – EU, UK, Australia,
US, Canada, WHO & Emerging Markets

Drug Product Regulatory – EU, UK, Australia, US, Canada, WHO & Emerging Markets

End to End Regulatory Services covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authorities, Deficiency response, Pricing approval, Local M1 Support, Marketing Authorization & Product Life Cycle Management.

  • Guidance on technical and administrative requirements for dossier preparation
  • Evaluation and recommendations on regulatory filing routes
  • Provide molecule-specific technical guidance aligned with ICH, EMA, FDA, and other agency requirements, addressing CMC, clinical, and nonclinical data expectations
  • Define filing timelines, slot booking, and authority engagement plans
  • Roadmap for regulatory approval, fees, time frame for submissions
  • Strategic decision-making for the selection of filing countries and procedures
  • Scientific evaluation of quality (Module 3) data as per regulatory guidelines
  • Assessment of batch manufacturing records (BMRs), specifications, process validation, analytical validation, and stability data
  • Identification and resolution of technical issues during validation batch reviews

Module 1: Regional and Administrative Information

  • Cover Letter, Product Information (SmPC, PIL, Labelling), Mock-ups, Specimens
  • Draft expert reports for clinical and non-clinical modules
  • Provide guidance on CMC expert report structure and content
  • Information related to pharmacovigilance (PV) and Marketing Authorization Holder (MAH)
  • Facilitate local Module 1 support across global markets, ensuring compliance with region-specific administrative requirements

Module 2: Overviews and Summaries

  • Authoring of Module 2.4 (Nonclinical Overview), 2.5 (Clinical Overview), 2.6 (Nonclinical Written and Tabulated Summaries), and 2.7 (Clinical Summaries)
  • Development of Modules 4 and 5 based on peer-reviewed literature and authoritative reference sources for the target molecule
  • Scientific integrity ensured through alignment with applicable international guidelines

Module 3: Quality Documentation

  • Comprehensive authoring of Module 3, encompassing manufacturing processes, control strategies, analytical validation, and stability data
  • Leverage client-provided technical documentation and source data for dossier preparation
  • eCTD publishing to be executed by client or designated partner

Module 4: Submission to Regulatory Authority

  • Coordinate dossier compilation and formatting for electronic submission per regional requirements (e.g., eCTD)
  • Liaise with regulatory authorities and manage submission timelines
  • Review and verify submission packages for completeness and technical accuracy

Module 5: Post-Submission Query Management

  • Scientific review of authority questions and preparation of response strategies
  • Drafting of response documents based on client-provided source data
  • Coordination with local agents or regulatory contacts for submission of responses
  • Support in maintaining communication with regulatory authorities throughout the review cycle

Module 1: Regional and Administrative Information

  • Cover Letter, Product Information (SmPC, PIL, Labelling), Mock-ups, Specimens
  • Draft expert reports for clinical and non-clinical modules
  • Provide guidance on CMC expert report structure and content
  • Information related to pharmacovigilance (PV) and Marketing Authorization Holder (MAH)
  • Facilitate local Module 1 support across global markets, ensuring compliance with region-specific administrative requirements

Module 2: Overviews and Summaries

  • Authoring of Module 2.4 (Nonclinical Overview), 2.5 (Clinical Overview), 2.6 (Nonclinical Written and Tabulated Summaries), and 2.7 (Clinical Summaries)
  • Development of Modules 4 and 5 based on peer-reviewed literature and authoritative reference sources for the target molecule
  • Scientific integrity ensured through alignment with applicable international guidelines

Module 3: Quality Documentation

  • Comprehensive authoring of Module 3, encompassing manufacturing processes, control strategies, analytical validation, and stability data
  • Leverage client-provided technical documentation and source data for dossier preparation
  • eCTD publishing to be executed by client or designated partner

Module 4: Submission to Regulatory Authority

  • Coordinate dossier compilation and formatting for electronic submission per regional requirements (e.g., eCTD)
  • Liaise with regulatory authorities and manage submission timelines
  • Review and verify submission packages for completeness and technical accuracy

Module 5: Post-Submission Query Management

  • Scientific review of authority questions and preparation of response strategies
  • Drafting of response documents based on client-provided source data
  • Coordination with local agents or regulatory contacts for submission of responses
  • Support in maintaining communication with regulatory authorities throughout the review cycle

Europe

  • Support strategic EU market entry through country selection, procedure planning, and slot booking for National and DCP submissions
  • Provide product-specific scientific advice and perform regulatory gap analysis
  • Author CTD dossier across all Modules, ensuring compliance with EMA expectations
  • Facilitate closure of local Module 1 documentation, including MAH, QPPV, EU BRS, translations, ERA, RUT, RMP, and other region-specific elements
  • Scientific Advice from regulatory agency for clinical studies. Support in preparation of Scientific Advice package for the Agency

United Kingdom

  • Provide end-to-end support for MHRA national submissions, including regulatory strategy, slot planning, and dossier preparation and submission
  • Support for QP audits, batch release site identification, and QPPV assignment
  • Evaluate SME eligibility for regulatory fee reductions and facilitate pharmacovigilance system setup
  • Local Module 1 documentation support

Australia

  • Guidance on TGA requirements and COR eligibility
  • Support alternative access pathways including Section 19A and Special Access Scheme (SAS)
  • Experienced in TGA GMP Compliance Verifications through Desktop Assessments for pharmaceutical manufacturing sites
  • Authorized sponsor for holding MAs and enabling local marketing/distribution tie-ups

United States

  • Regulatory pathway determination and pre-IND strategy
  • Authoring of CTD modules with emphasis on CMC (Module 3) and summaries
  • Control correspondence submission via CDER Direct Nex Gen Collaboration Portal
  • Liasoning for receipt of Control Correspondence number, ANDA number, DUNS number, NDC number
  • Compliance of dossier review with respect to refuse to receive (RTR) guidance.
  • Query and deficiency response to Information request (IR), Discipline Review Letter (DRL), Complete Response Letter (CRL)
  • Support for lifecycle management and post approval change submission (CBE-0, CBE-30, PAS, Annual report)

Emerging Markets (Africa, Asia, LATAM, CIS, Middle East)

  • Regulatory Due Diligence of Technical Data against prevailing guidelines of the respective country
  • CTD/ACTD/Country specific dossier compilation
  • Support for pre-submission advisory meetings/ Scientific advice packages, agency meetings
  • Representing MAA review committees at agency level
  • National application writing, submission, query response and approval

REGULATORY SUPPORT FOR SUBMISSION VIA ACCESS CONSORTIUM.

End–to–end regulatory support for dossier submission to ACCESS countries

The ‘ACCESS’ consortium, formed in 2007, comprises of the national regulatory authorities of Australia, Canada, Singapore and Switzerland. ACCESS – In October 2020, the United Kingdom regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – joined the consortium and the group’s name was changed to ‘Access’. The consortium’s goal is to maximize international cooperation, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products. Pharmaceutical companies that submit applications to some or all Access countries will benefit from having their products evaluated for marketing in those countries simultaneously, with reduced evaluation times.

TGA – Australia

Regulatory guidance & advice on TGA Biosimilar guidelines “Biosimilar Medicines Regulation, Version 2.2, 2018”

HC-BRDD – Canada

Regulatory guidance & advice on HC/BRDD Biosimilar guidelines “Guidance Document: Information & Submission requirements for Biosimilar Biologic drugs, 2017”

MHRA – United Kingdom

Regulatory advice on “MHRA guidance on the licensing of biosimilar products, October 2020”

HSA – Singapore

Regulatory guidance & advice on “Guidance on Therapeutic Product Registration in Singapore, December 2020”

SWISSMEDIC – Switzerland

Regulatory guidance on Swissmedic Biosimilar guidelines “ZL101_00_012e_WL Guidance document Authorization biosimilar HMV4, V3.1,2021”