• REGULATORY AFFAIRS
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Regulatory Affairs is an area of rapid change and ever increasing complexity. Healthcare and life science companies need to work smarter than ever before. Regulatory outsourcing is a key strategy that assist companies to focus on their core competencies and innovations. At HERMS, we understand the regulatory process and can support your product to approval and commercialization. From general compliance issues, reporting requirements and product dossier submissions, HERMS has the expertise to help manufacturers navigate the often confusing regulations, policies, guidelines, and practices in an ever changing regulatory environment. HERMS ability to assess issues and provide strategic planning is efficient and unique. In serving clients’ needs we add value to avoid high costs and irreversible mistakes. When submitting marketing authorization application, HERMS focuses on achieving registration and commercialization in a timely manner. Our focus considers your need to maintain a long term and compliant market presence. On compliance issues ,we support our clients to avoid the often times serious consequences which can arise through actions imposed by the regulators

REGULATORY AFFAIRS

General regulatory solutions

We work with all related authorities such as ministries of health , municipalities, and others.

  • Regulatory affairs strategy development
  • Innovative regulatory roadmaps
  • Good manufacturing practice (GMP)
  • Promotional and advertising material approvals
  • Product patency and trademark protection and registration
  • Regulatory Intelligence
  • Importation process approvals


Product specific regulatory Solutions

We cover all regulatory activities for products from Pharmaceutical, Generic, Medical Device, Biotechnology, Biosimilar, Consumer Healthcare, Cosmetics, Supplement and Herbal companies such as:

  • Company and Manufacturer Registration and Renewal
  • Product classification
  • New product registration
  • Product lifecycle management (variations and renewals)
  • Regulatory document preparation
  • Dossier preparation (CTD & e-CTD) and submission
  • Medical Writing
  • Labeling validation and modification
  • Medical translation (e.g., labels and leaflets)
  • Laboratory testing and analysis
  • Product value assessment and product value dossier
  • Value-based pricing strategy and reimbursement analysis
  • Pharmacovigilance guidance regarding authorities’ guidelines


    LIFE CYCLE MANAGEMENT

  • • CMC Annual Report Submissions:

    • Provide CMC lifecycle management Regulatory strategy and timelines for the required documents. 
    • Request for a list of changes implemented in the reporting period along with CMC documentation.
    • Regulatory assessment of the supporting documents and request for additional documents/justification.
    • Finalization of the Annual Report package and submission in the eCTD format.
    • Updating the database with submission details and status.

  • • Renewal Applications:

    • Send the renewal initiation documents request to the manufacturer and request for CMC documentation.
    • Regulatory assessment of the supporting documents for renewal application submission.
    • Finalization of renewal dossier and submission to the Health Authority before the renewal application due date.
    • Update the database with submission details.

  • • Post-Approval Changes Submissions:

    • Change in manufacturing site, addition/deletion.
    • Marketing Authorization Holder transfers.
    • Optimization of manufacturing process, changes in formulation and or batch size changes.
    • Inclusion of additional source for starting material for drug substance.
    • Specifications and analytical method changes.
    • Changes in container closure system and suppliers.
    • Shelf-life extension/reduction.
    • Implementation strategy and timelines and guidance on supporting documents/data.
    • Preparation of Supplement/Variation/Amendment Package.
    • Interaction and follow-up with Health Authorities for approval and implementation.
    • CMC Regulatory compliance of legacy dossiers/submissions with post-approval supplements/CMC variations.


MARKET ACCESS

  • Health economics and outcomes research (HEOR)
  • Market Access Strategy
  • Pricing and Reimbursement


​​​​​​​MEDICAL WRITING

  • Clinical Trial and Nonclinical Regulatory Services
  • Regulatory/Medical Review of Ad Promo Material
  • Pharmacovigilance, ICSR Services, Literature Monitoring Services, Aggregate Safety Reports, Signal Management
  • Risk Management
  • Medical Device PMS/Vigilance


PUBLISHING & SUBMISSIONS

  • Regional eCTD Publishing and Submission Services
  • NeeS Submissions
  • Paper Submissions
  • Drug Master File (DMF) Submissions
  • Regulatory/Medical Review of Ad Promo Material


LABELLING

  • Regional Labeling for Pharmaceuticals, Medical Devices, Cosmetics and Supplements
  • Labeling Compliance


REGULATORY INTELLIGENCE

  • Regulatory Intelligence for Pharmaceuticals, Medical Devices, Cosmetics and Supplements
  • Regulatory Market Intelligence Reports


REGULATORY COMPLIANCE

  • Regulatory Compliance/Gap analysis of the supporting documents.
  • Review of the qualitative, quantitative composition and Impurity limits of the product.
  • Gap analysis of the protocols/reports for product development, process validation, stability program, exhibit batches, batch size for registration, and hold time study.
  • Biowaiver criteria.
  • Assessment of existing dossier for market expansion.
  • Region-specific stability study requirements.
  • Gap analysis of the variation/supplement submission strategy and suggestions.