Regulatory Affairs and Consulting

A multi-disciplinary team of qualified regulatory affairs consultants is at your disposal for all aspects of your clinical trial applications and marketing authorization applications for human medicinal products. SGS Regulatory Affairs can help you explore the shortest route and timeframe to put your products on the market, and support the Life Cycle Management of your products. The SGS Regulatory Affairs team provides full regulatory support from pre-clinical to post-marketing.

At the pre-registration phase, we support your scientific advice requests, prepare and review Investigational Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB), and provide advice on regulatory submission strategy. Our consultancy includes advice on informed consent applications and bibliographic submissions and covers numerous product types:

• Orphan drug (designations)
• Biologicals 
• Biotech products and advanced therapies
• Biosimilars
• Generics 
• NCE’s

With strong expertise in the preparation and review of clinical trial applications, SGS guides you through your clinical trial applications in Europe, Canada and US, using our regulatory knowledge database (drug import regulations and procedures) of over 50 countries. We provide the necessary resources for hands-on submissions, insurance certificates, import licenses and Qualified Person (QP) for GMP certification.

If you are aiming to market your product in Europe, SGS will closely collaborate with your team, and develop a tailor-made regulatory strategy for your product (portfolio) and guide you through the different procedural hurdles and authority interactions. We support all procedures (national, mutual recognition, decentralized and centralized) with preparation, review and submission of your Marketing Authorization Applications.

Post-registration, SGS’s Regulatory Affairs will support the maintenance and Life Cycle Management of your products, with support to your variations, line extensions, renewals, PSUR submissions and responses to Authority requests.

SGS also provides full regulatory technical support, such as liaison support with EU Health Authorities (NCAs, EMA), filing through eCTD, NeeS and paper, preparation and review of CMC part, handling of DMF files and writing of expert reports, readability testing on package leaflets, artwork review and handling of product information documents. Our staff is available for temporary regulatory support on-site with the client.

Our flexible, fast and continuous QP services include QP for batch release and distribution, QP for information and advertising and QPPV, including SOP writing and auditing. 

Contact SGS today to discover how we can help with your pre- and post-registration regulatory requirements.

• Clinical Safety & Regulatory Submissions

  Complete Regulatory and Safety Services (PDF 1.4MB)
  Safety & Regulatory (1496 KB)
• Development, Registration, Post-Authorization

  Quality in services from start to finish (PDF 2.6MB)
  Development (2676 KB)

• eCTD – Optimal Product Life Cycle Management

  Navigating the challenges of eCTD (PDF 104KB)
  eCTD (104 KB)
• Marketing Authorization Procedures in the EU

  Choosing the right procedure – MRP, DCP, or CP (PDF 180KB)
  Authorization Procedures (180 KB)

Regulatory Inputfor Clinical Trials WebinarClinical TrialsOptimizing drug development with regulatory input

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All 6 resources

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  Safety & Regulatory

  published 02/29/12

  PDF

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  Development

  published 02/29/12

  PDF

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  eCTD

  published 02/29/12

  PDF

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  Authorization Procedures

  published 02/29/12

  PDF

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  Regulatory Input

  published 02/28/12

  Video

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  Interactive Pocket Map

  published 06/06/12

  Video