Regulatory Affairs Services

PharmaVigilance encompasses the reputable Regulatory Affairs team, which comprises of experienced professionals, who provide simplified assistance in the drug approval process for various geographical areas, especially for Europe and the United States.

Active involvement of Regulatory Affairs in the development process of a new medicinal product up to its post-marketing authorisation has ranked the importance of Regulatory Affairs. Our PharmaVigilance Regulatory Affairs team has been ideally placed to offer you full support service throughout this process.

To protect public health, PharmaVigilance with its Regulatory Affairs team continuously appraise the quality, safety and efficacy of the drug products. We provide proficient regulatory support for all the areas of pharmaceuticals such as; medical devices, cosmetics and complementary medicines.

Writing Dossiers

PharmaVigilance team can offer full regulatory support, which includes writing, reviewing and publishing of the dossier for pharmaceutical products, biological products and medical devices. If you are aiming for the marketing authorisation of your product in Europe and the United States (US), PharmaVigilance will closely collaborate with your team, and develop a tailor-made regulatory strategy for your product (portfolio) and guide you through the different procedural hurdles and authority interactions.

We support all procedures [National Procedure (NP), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and Centralised Procedure (CP)] and applications [Investigational New Drug Application (INDA), NDA, Biologics License Application (BLA) and Abbreviated New Drug Application (ANDA)] for the preparation, review, submission (including publishing) and lifecycle management of your Marketing Authorisation Applications. We can also develop and submit dossiers for Commonwealth of Independent States (CIS) countries and Rest of World (ROW) countries for successful registration.

Our team is highly experienced in reviewing the existing dossiers as per the client requirements. Our team includes expert Regulatory Affairs associates and regulatory operations professionals who are experienced and skilled in the preparation, compilation and publication of regulatory submissions. Our team brings together relevant knowledge, skill and expertise to ensure your success with high standards of services. We pride ourselves in maintaining our principles of accuracy, timeliness and responsiveness throughout the entire regulatory lifecycle.
We can support you with the writing & reviewing of:

  • All Common Technical Document (CTD)/eCTD modules;
  • Non-Clinical and Clinical Overviews & Summaries;
  • Safety and Efficacy Overviews & Summaries;
  • Module 1 to 5 for the Drug Product Dossier (for MAA, NDA and ANDA);
  • Module 1 to 3 for the Drug Master File (DMF) [for US DMF and Active Substance Master File (ASMF)];
  • European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability applications (CEP);
  • Labelling;
  • All parts (I to IV) of ASEAN Common Technical Dossier (ACTD);
  • Investigational Medicinal Product Dossier (IMPD).

Pre-Approval Assistance

We can assist you throughout the pre-approval procedure, with our following services:
  • Preparation, Compilation and Publishing of dossiers as per EU legislation for MAA via CP, NP, MRP and DCP;
  • Preparation, Compilation and Publishing of dossiers as per United States Food and Drug Administration (US FDA) requirements for INDA, NDA, BLA and ANDA;
  • Preparation, Compilation and Publishing of eCTD dossier for Australia, South Africa and Canada;
  • Preparation, Compilation and Publishing of DMF (US DMF and ASMF) and CEP dossier for the Marketing Authorisation in the United States of America and Europe;
  • Preparation of bibliographic and line extension applications for EU regions;
  • Publishing of Structured Product Labelling (SPL);
  • Preparation of product information [Summary of Product Characteristics (SmPC)/Patient Information Leaflets (PIL)/Package Leaflet (PL)] and mock-ups.

Post-Marketing Assistance

Allow us to convert the market information into valuable data of your interest through our following specialised services:
  • Lifecycle management of the submitted dossiers;
  • Preparation for and assistance in submission of Amendments/Supplements/Variations filing to marketing authorisations;
  • Annual, Biannual and Quinquennial reports for IND, BLA, MAA, NDA and ANDA;
  • Renewal of licenses for CIS and ROW countries;
  • Assistance with EU renewal procedures (CP/NP/MRP/DCP) at each step starting from preparing the application form, to compiling the documentation, to granting the renewal;
  • Providing responses within stipulated timelines on queries/deficiencies raised by health authorities and customers.