Consulting

Consulting

In every drug development program, there are those challenges that can sometimes not only affect your submission timelines but your approved products. Your plan and strategy to reduce and react to these challenges can affect the promising new product. At GLS, we partner with you to help identify and evaluate these challenges to provide you with customized and effective solutions……Solutions that are based on an integrated lifecycle approach that combines your pre/post approval information and speed.

With extensive collective experience in global drug development process and global regulatory requirements, we can provide you with the expertise to help develop an effective strategy and plan for different product types and markets. These expertise include advise on regulatory filings to consultations on complex scientific and regulatory issues. Our ability to provide these cost effective and quality solutions comes from our strategic alliances with qualified local resources, institutions and extensive understanding of the local regulations.

Our services include:

  • Quality Systems Development and Management
  • Vendor Selection and Management
  • Training
  • Audit Management
  • Qualified Person Services
  • Risk Assessment and Management
  • Risk Assessment & Management
  • Global Regulatory Strategy and Support
  • Study/Project Maintenance and Remediation
  • Validation/Qualification Activities
  • Records Management
  • Export and Import support
  • Translation support
  • Commissioning
  • Brand Protection/ Anti- Counterfeiting Services
  • New Technologies

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Therapeutic Areas

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Contacts

  Contact Us

  +1 (516) 859-4312

  info@guosalifesciences.com

   708 3rd Avenue, 6th Floor
New York, New York, 10017, USA