Pre-Approval
Essential regulatory support for your important first steps on the path to market approval
Pre-Approval
Essential regulatory support for your important first steps on the path to market approval
Charting your path to market approval
At G&L, we understand that the foundation of a successful regulatory strategy must be in place before a product can reach the market.
Our services are designed to help you navigate the early stages of drug development with confidence.
Our expertise spans all therapeutic areas and stages of drug discovery and development, ensuring that you have the guidance needed to define your strategy and identify the fastest, clearest route to market.
Regulatory strategy development
We work with you to create a regulatory roadmap to success, tailored to your product and target markets to build the foundation of a successful approval.
With regulatory expertise across over 100 markets worldwide, let G&L inform your regulatory strategy to unlock new markets and revenue streams.
Services include:
- Regulatory and market strategy
- Regulatory roadmaps and program assessment
- Local regulatory intelligence
- Regulatory and competitor intelligence
- Product design and CMC development
- Expedited review: fast track, breakthrough therapy, accelerated approval, priority review, RMAT, PRIME
- Orphan designation
- Pediatric plans (PSP/PIP)
- Risk management plans and labeling
- Target Product Profile (TPP)
Health Authority interactions
Our team, which includes former Agency staff, ensures that you are fully prepared for interactions with health authorities worldwide, from the FDA to the EMA and beyond.
Whether you require us to prepare, lead or drive key meetings, G&L has the expertise to navigate critical agency discussions and negotiations.
Services include:
- Meeting requests and Briefing Books
- Pre-IND/pre-NDA/BLA strategy and support
- INTERACT, innovation council
- Pre-IND, EOP2, pre-NDA/pre-BLA, AdCom, CMC, Scientific Advice meetings, etc.
- Label negotiation interactions
Clinical submissions
We partner with you to navigate the complexities of clinical regulations, and ensure your clinical submissions are authored and filed efficiently to accelerate your path to market.
Our teams of regulatory and clinical experts, technical and medical writers, and local experts in over 100 markets worldwide are perfectly placed and ready to support your clinical submissions from both a strategic and tactical perspective.
Services include:
- Clinical and non-clinical development plans
- Investigator’s Brochures (IBs), protocols, Clinical Studies Reports (CSRs)
- INDs/CTAs/IMPDs (Phase I – IV studies)
- IND amendments/CTA updates
- IND annual reports/DSURs
Experience you can trust
0+
250+
Agency meetings
0+
300+
CTA/IND filings
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600+
MAA/NDA/BLA filings
View our case studies
Our client success stories
