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Filing Strategy

G&L recognizes the huge commercial value of accelerated drug development and market approval.

The company is a recognized expert in creating innovative regulatory roadmaps from early development right through to successful approval and beyond in any market around the world. G&L is relentless in the pursuit of excellence and quality in every aspect of its work and, as a result, has earned an exceptional reputation in the industry for getting things ‘right first time.’ Regulatory Development and Filing Strategy services include:

  • Agency meetings, Scientific Advice / Protocol Assistance
  • Advisory Committee meetings & preparation
  • Clinical Trial Filing (CTA and IND)
  • Investigator Brochure / IMPD / IND authoring
  • Risk management planning
  • Early Access Programs, PRIME, Breakthrough Therapy Designation
  • Paediatric Investigation Plans (PIPs), Orphan Designations
  • Expert Advice (Non-Clinical, Clinical and Quality)
  • Global Regulatory Intelligence

“With G&L, our small Regulatory Affairs department hit the jackpot. As we were looking for substantial tactical, CMC and strategic support to our filings within the EEA, G&L facilitated and enabled the search for the right expertise that would meet our needs. Within a quick turnaround, unmatched in speed and efficiency by any other firms we have worked with in recent past, she was able to find for us three regulatory consultants, all based in the UK, who have been providing us with invaluable insights and technical help.

“By virtue of the contributions of the experts that G&L could so deftly find for us, we were able to march towards the ambitious achievements that our business was expecting from our department, and meet our goals for the year. I don’t know how we could have pulled this off without G&L!”

Medium-sized US Biopharmaceutical organization.

Contact us today

For more information on Filing Strategy, please fill in the form and we will respond to you as soon as possible.

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