Staff Augmentation over entire gamut of the Life Sciences value chain
- Over-the Counter products
- Finished Products
- Medical Devices
- NDA support work
- ANDA support work
- 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).
- 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.