• Pre-IND meeting preparation, communication with US-FDA, EMA (end-to end)
  • Develop regulatory strategy
  • Investigational New Drug (IND) preparation, submission (CBER, CDER)
  • eCTD submission to regulatory agencies
  • Type A, B, C, EOP1, EOP2, pre-NDA meetings preparation and communication
  • Preparation and submission for Orphan Drug Designation (ODD), Priority Review
  • Voucher (PRV), Qualified Infectious Diseases Product (QIDP) designation
  • Special protocol Assessments (SPA)

Regulatory and Medical Writing

In any drug development program for any therapeutic area two important milestones are critical, one, interaction with the regulatory authorities and second, dissemination of the outcome of the clinical development program to the research community and the public at large. This involved a dedicated sustained efforts and research, infused with millions of dollars investment. Hence, it is utmost important to create, review and finalize these regulatory submission documents (e.g. pre-IND, IND, NDA, BLA, ANDA, CSR, IB, protocol etc.) under an expert review and care. It is also a critical step to prepare these reports/documents with scientific rigor, methodological detail and all of the information necessary to support a clear interpretation of the analysis and conclusions.

Our team have an extensive experience of working in drug discovery, non-clinical, formulation and clinical development programs with a concrete understanding of the regulatory landscape. This unique exposure help our translational clinical pharmacologist to connect the scientific dots efficiently and with a translational science approach to do a scientific and regulatory justice to the product under study.

Key services include:
  • Pre-IND, NDA, BLA authorship, compilation, correspondence and submission to US-FDA
  • 505(b)(2) authorship, compilation, correspondence and submission to US-FDA
  • Writing the clinical modules as per CTD
  • Writing high scientific quality clinical study protocol, IB, CSR, PIS etc.
  • Consult to the sponsors on planning non-clinical and clinical development plans

Medical Writing

Our highly motivated and educated (Ph.D.’s, MS) medical writers include members of the American Medical Writers Association (AMWA) and members as well as Fellow of the American College of Clinical Pharmacology, (ACCP), who have greatly benefited from the highly specialized training from these professional organizations. Our team works with the “Team Science” spirit with a translational research approach. This dynamic team writes and edits broad spectrum of documentation, for internal and external company/client use, regulatory submissions, publication or marketing support. While drafting these high-quality documents we follow GPP3, ICMJE and other related guidelines based on the specificity of the writing need.

Our medical writing staff have experience in the therapeutic areas of cardiovascular, dermatology, critical care, autoimmune, diabetes/endocrine, neuroscience, oncology and infectious diseases. All the scientific documents produced by our medical writing team are thoroughly reviewed and undergo complete QC during editorial review before submission to the client.

Key services include:
  • Publication planning, implementation
  • Original research manuscripts
  • Letter to the Editor
  • Review manuscript
  • Systematic review
  • Meta- analysis
  • Congress abstracts, posters, and oral presentations
  • End to end submission to the scientific journals
  • Review of the scientific manuscripts
  • Newsletters, congress reports, and sponsored journals
  • Slide decks, narrative reviews