G&L Scientific provides consulting, staffing and support services for Clinical Research and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of 2,500 consultants in over 100 countries, we can find the right professional, at the right level, in the right location to fulfill your staffing needs. Building a cohesive team that can meet aggressive deadlines is a daily challenge in the industry. With our highly experienced, multi-disciplinary background, we ensure your team is always at full strength and operating at maximum capacity. All our consultants are experienced in the use of multiple systems to speed up the onboarding process. Hand-picked by our in-house experts with your specific project in mind, they are continually overseen by us to ensure they’re exceeding your expectations. Whether you need an individual or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings to your resource budget, and allows you to flex your headcount in line with operational demands.

1. CLINICAL CONSULTING
• Our early and late phase Clinical Scientists are medically and/or Ph.D qualified. They provide:
- Scientific consultancy for individual protocols or complete clinical development programs
CLINICAL PROJECT MANAGEMENT
• Quality deliverables on time and on budget
• Our Project Managers’ experience includes:
- Study planning through to study completion
- Managing teams, study processes other study-related 3rd parties
DATA MANAGEMENT & STATISTICS
• Consultants with experience and in-depth therapeutic knowledge across all study phases
• End-to-end statistical analysis including clinical study design through to reporting of results
STRATEGIC OUTSOURCING & DEVELOPMENT
• Scalable, dedicated teams focused on creating long-term partnerships with Clients
- All levels of experience with specific skillset - Efficient
- Cost-effective - Measurable results
MEDICAL WRITING
• Experience across all kinds of medical writing and therapy areas:
Manuscripts, Clinical Documents, Investigator Brochures, Journals
• Native English writers
• Local language writers
CLINICAL MONITORING
• Our Monitors are experienced across all geographical regions and all study phases,
including varying levels of complexity
• We ensure the study is completed according to the approved protocol, ICH/GCP
guidelines and any local regulatory requirements
CLINICAL SUPPLIES
• Our staff plan, forecast and manage supply of Study Drug through all phases of the study
• We ensure Study Drug is at the right place, at the right time
• Familiar with local regulations and timelines for export/import of Study Drug
ACROSS MULTIPLE AREAS:
Oncology, Neurology and CNS, Cardiovascular, Pain, Respiratory, Dermatologics, GI, Vaccines, Immunology, Infectious Diseases, Nephrology
CLINICAL RESEARCH
www.gandlscientific.com
US Head office: Millburn, NJ;
T: +1 973 232 0811
E: hello.millburn@gandlscientific.com
European Head office: Dublin, Ireland;
T: +353 1 66 41 445
E: hello.dublin@gandlscientific.com
UK Head office: Marlow, Buckinghamshire;
T: +44 1628 400686
E: hello.marlow@gandlscientific.com

2. OUTSOURCING
Over the past 10 years, Outsourcing has become a hot topic within Regulatory Affairs: everyone is doing it. But is it right for your
business, and what should you outsource?
• G&L will give you the very best advice by:
- listening to what you say, to gain a deep understanding of your business
- strategizing on how to achieve your goals through working with external agencies
- working in genuine partnership with you for as long as you need us
COMPLIANCE REVIEWS & REMEDIATION
The pressure on businesses to ensure CMC Regulatory Compliance has never been higher, in terms of potential penalties, litigation and
impact on brand perception.
• G&L supports compliance efforts by:
- Reviewing your License against manufacturing processes and practices - Conducting Gap Analyses to highlight non-compliance issues
- Putting a Remediation Plan in place - Preparing Variations and submitting to relevant Agency
LICENSE MAINTENANCE
The License Holder is legally responsible for making sure their License is properly maintained, and the product is strictly manufactured
to approved terms
• G&L has extensive experience in conducting License Maintenance activities across the world, with many different Health Agencies and
all product types:
- Putting License Maintenance processes in place before Marketing Authorization is granted to minimize risk of future compliance issues
- Post-approval activities, including preparation and submission of Variations, Renewals, Line Extensions and Safety Updates
MEDICAL WRITING
• Our native English writers and local language writers are experienced across a wide range of medical and scientific subjects,
multiple therapy areas and product types
• Clinical Documents: Investigator Brochures, Protocols/ICs, Clinical Study Reports, Clinical Expert Reports
• All Modules of the Application Dossier: Administrative, Non-Clinical, Clinical
• Journals • Manuscripts • Conferences • Abstracts
DOSSIER PREPARATION & SUBMISSION
Carefully-considered, well-written and comprehensive submission packages are a central factor in achieving regulatory approvals in a timely manner
• Familiarity with the regulations and timelines of different Health Agencies around the world, for successful submission and speedy approval
• All product types covered, including Biotechnology, Pharmaceuticals, Medical Devices, Consumer Healthcare and Generics
• Assurance that your dossier contains the correct technical data for approval (Administrative, Quality, Non-Clinical and Clinical)
• Submission of application and liaison with the Agency
REGULATORY STRATEGY
The effective application of scientific, product-specific and local knowledge is at the foundation of a
successfully-executed Regulatory Strategy.
• Regulatory Strategy specific to product type and approval market
• Our experts will work closely with you to understand and achieve your goals:
- Solid, well-planned strategic roadmap for product registration, minimizing delays in approval
- Deep expertise in all phases of drug lifecycle, including pre-clinical, clinical, CMC and post-approval
- In-country consultants in over 100 markets, best placed to advise on regional/national regulations and local hurdles
• Detailed post-approval advice on requirements to maintain your license
GLOBAL REGULATORY INTELLIGENCE
Access to current, validated and first-hand Regulatory Intelligence has never been so important, in order to
successfully navigate approval pathways in new markets.
• Current, validated and relevant Regulatory Intelligence to register products in new markets
• Local knowledge from experts working in the field
• Our Global Scientific Partner Network saves you time, money and stress:
- Provision of critical, tailored Regulatory Intelligence - Right-first-time submissions - Faster approvals
REGULATORY AFFAIRS
ACROSS MULTIPLE AREAS:
Pharmaceutical, Biotechnology, Consumer Healthcare, Medical Devices, Generics, Veterinary
www.gandlscientific.com
US Head office: Millburn, NJ;
T: +1 973 232 0811
E: hello.millburn@gandlscientific.com
European Head office: Dublin, Ireland;
T: +353 1 66 41 445
E: hello.dublin@gandlscientific.com
UK Head office: Marlow, Buckinghamshire;
T: +44 1628 400686
E: hello.marlow@gandlscientific.com