Medico Regulatory Services

 

Our team has experts who have good writing skills, relevant medical/scientific education, and experience to produce expertly-written documents – on time. We strive for clarity, efficiency of presentation, and scientific accuracy. All of our medical writing deliverables undergo a rigorous quality editing and QC review to ensure they look good, read well, accurately interpret the study results, and comply with regulatory and stylistic guidelines.


In addition we have dedicated resources which provide regulatory solutions to support clients’ product development programs. We can also provide on-going regulatory support once your product is registered. Our broad functional and therapeutic area expertise enables us to provide specialized inputs to clients according to their needs. We have substantial experience in European regulatory arena.

 

We provide following services:

  • Commercial writing


    Product monographs
    Simulated case report
    Patient education material
    Slide kits for CMEs, training and product launch
  • Publication support


    Research manuscript
    Review articles
    Data analysis
    Systemic review and meta-analysis
  • Regulatory Support


    Common Technical Document (CTD)
    Quality Review Documents (QRD’s)
    Artworks
    Clinical expert statement (CES)

  • Regulatory Consulting


    Regulatory assistance for EU (EMEA) compliance to Pharmacovigilance.
    Regulatory strategic inputs for Food Supplement/Neutraceutical Development Plan in:
    Federal Trade Commission, FTC – USA
    Food & Drug administration, FDA – USA
    European Food & Safety Authority, EFSA - Europe
    Natural health product directorate, NHPD – Canada
    Therapeutic Good Administration, TGA – Australia
    Food Standards Authority – New Zealand
    National Pharmaceutical Control Bureau – Malaysia
    Preparation of Product Registration applications, Drug Master Files and Post –approval regulatory     submissions (renewals and variations).
    Project Management and co-ordination of registration applications including interfacing with Regulatory Authorities on behalf of clients.


Services & Facilities

     
  Clinical Research
  Medico-regulatory
  Discovery Biology
   

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