Services

We would like take an opportunity to introduce our pharmaceuticals services at Help Pharma Solution.

Services Synopsis

  • GMP & WHO-GMP Documentation consulting
  • Plant Setup
  • Dossier Preparation (CTD/ACTD)
  • Provide BE Studies and Clinical Trial Studies
  • DMF Preparation
  • Internal Audit
  • Quality Assurance & Personnel Training
  • Regulatory Services and Training
  • Third Party Vendor Audit
  • Embassy Legalization

Pharmaceutical Measures

  • GMP and WHO GMP compliance
  • Customized Plant Set up
  • External GMP Audit
  • Regulatory Affairs Directive
  • Formulation and Development
  • Licensing with local FDA, DCGI etc.

Regulatory Services

  • Dossier Preparation (CTD/ACTD)
  • Regulatory Query Response
  • Method Validation for Finished Product
  • DMF
  • Stability Studies
  • BA/BE studies complying with WHO and EMEA
  • Guideline from DCGI approved BE centers
  • Evaluation of regulatory requirements for BE studies
  • Clinical Trial (CT Reports)
  • Acute,Sub-acute and Chronic Toxicity studies

Quality Assurance

  • SOP Development
  • DQ, IQ ,OQ, PQ solution
  • Vendor Audit
  • Area classification
  • Method Validation, Cleaning Validation,
  • Process Validation
  • External Lab Services

Training Programs

  • Class Room Training
  • GMP Training
  • Validation concept like Clinical Validation,
    Process Validation, Method Validation
  • SOP Training

Job Recruitment's

We believe hiring to be the most important first
step towards the organization’s success and therefore
we provide filtered recruitment solution for
pharmaceutical companies.

Contact Us...

Please feel free to contact us for any further queries and we would be happy to assist you.