Staff Augmentation over entire gamut of the Life Sciences value chain


  • Pharmaceutical
  • Biotechnology
  • Over-the Counter products
  • APIs
  • Finished Products
  • Excipients
  • Nutraceuticals
  • Medical Devices
  • NDA support work
  • ANDA support work

Business Value

  • Enhance regulatory compliance and improve quality of the product.


Avco provides solutions in Quality Systems compliance, Quality Assurance and Quality Control.

  • GMP and FDA-Related Services
  • Due Diligence Audits - CMOs and CROs
  • Quality Assurance and Controls
  • System and Process Validation or Qualifications
  • Scientific and Technical Assistance
  • Training -GMP, Regulatory and Generic Programs
  • Product Assessments
  • Analytical Test method Validation
  • Computer System Validation
  • Review and Assess Data Integrity
  • Remediation plan
  • Stability Testing services


  • Reduce Cost and  Enhance efficiency in the Company.

Drug Safety Services


  • Draft DSMB charters, operation planning and risk management.
  • Protocol writing, compliance assessment, safety monitoring of clinical trials and maintenance of global safety data.
  • Surveillance of SAE/AE initial documentation, processing, causality evaluations, literature-based drug class perspective evaluation, narrative composition of serious adverse events (SAEs)/Adverse Events (AE).
  • Marketing services such as case intake/data entry, regulatory reporting, crisis management, dealing with litigation cases, literature search and narrative writings.
  • Data Collection (Lab data, imaging data, EKG and Qtc).
  • Medical (MedDRA and WHO-DD) coding, medical quality review, literature review and safety review of the cases.
  • MedWatch (FDA3500A) and drafting of periodic safety update Reports (PSURs).
  • Adverse event reporting and regulatory submission to US FDA, Canadian Health Authority and Indian Health Authority.
  • Pre-registration signaling, signal Detection, post-marketing signaling and post-marketing signal assessments.

Regulatory Affair Services


  • Development, preparation, assembly and submission of complete Common Technical Documentation (CTD) for marketing authorization applications (MAAs) in both Europe and the USA.
  • Drug master file (DMF) compilation in Common technical documentation (CTD) Format including Open, Close, Review and submission of DMF writing.
  • Preparation and submission (US, Canada and Europe).
  • Dossiers compilation in Common technical documentation (CTD) Format including Administrative Information, CTD Overview, Drug & Product Part/CMC, Non Clinical and Clinical.
  • Conversion of paper or NEES documents into electronic dossiers using e-CTD (electronic Common Technical Document) software.
  • Preparation of responses to regulatory authorities, comment letters and assessment reports.
  • Orphan drug designation/applications.
  • We provide regulatory services mainly in DMF, IND, Manufacturing, Import & Exports, CMC, NDA and ANDA.
  • We also involve in preparation of case report forms, Product information (SPC and PILS).

Validation Services


  • Equipment validation/ Commissioning and Qualification
  • Utility Qualification
  • Cleaning Validation
  • Process Validation
  • Computer System Validation
  • Analytical Method Validation

SAS Services / Biostatistics


  • Clinical programming expertise in using industry standard tool SAS.
  • Clinical submission packages including the capability to QA and QC the Tables, Listings and Figures using SAS.
  • All versions of SAS software across many platforms.
  • Clinical trial process, to provide comprehensive and effective SAS programming support.