LGM Pharma
制药业
Boca Raton，Florida 3,690 位关注者
We Accelerate and Optimize the New Product Pathway from Early Development Through Commercialization.
关于我们
LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical industry. We secure and optimize your supply chain with our extensive qualified API partner network, global drug product development and manufacturing facilities, and regulatory and market intelligence services delivering customized solutions that get your products to market faster. Full-service, expert support that accelerates the new product pathway. Now that’s smart. ? Established in 2005 ? ISO 9001-2015 QMS certified company ? CGMP systems in accordance with ICH Q7 ? Main business segments: R&D / Biotech / CDMO / Specialty Pharma Companies, New Drug Delivery Technologies (NDA/505b2) – with heavy concentration on injectables, transdermal, nasal, inhalation, ophthalmic & sublingual drug deliveries Our products originate from our API manufacturing partner sites who are approved by the leading regulatory authorities, such as the US-FDA, EDQM, TGA, UK-MHRA, PMDA etc. LGM’s industry experience enables us to support our clients throughout the entire pathway of drug development, from discovery through commercial production. Based on the scale and scope of development projects with which we are involved, we are able to provide our customers with a seasoned perspective and valuable market insight. LGM Pharma has enhanced its position as a leading supplier of newly approved APIs, including full technical documentation and regulatory support. Our Clients: At LGM Pharma, our clients’ needs are our top priority, and we support our client base consisting of a diverse array of pharma companies, including: ? Contract Research, Development & Manufacturing Organizations ? Specialty Pharma and Novel Drug Delivery Systems ? R&D & Biotech Companies ? Generic Pharma Companies ? Chemical Catalog Companies ? OTC & Private Label Manufacturers ? Academic & Government Laboratories ? Pharmacy Compounding Industry
- 网站
-
https://www.lgmpharma.com
LGM Pharma的外部链接
- 所属行业
- 制药业
- 规模
- 51-200 人
- 总部
- Boca Raton，Florida
- 类型
- 私人持股
- 创立
- 2005
- 领域
- CDMO、API Sourcing、Supply Chain Management、Drug Manufacturing、Drug Development、Regulatory Submission和505(b)(2)
地点
LGM Pharma员工
-
Naeem Ravat
Certified HCL/IBM/Lotus Notes Engineer | Multi-Cloud Solutions Architect | Azure | AWS | GCP | OCI | Domino Data Migration | Notes Developer |…
-
Shailesh Vengurlekar
Senior Vice President, Quality and Regulatory Affairs at LGM Pharma
-
Mike Stenberg
Vice President - Business Development at LGM Pharma
-
Julie Klaff
Partner at Origami Capital Partners
动态
-
????Do you struggle to bridge the gap between scientists and regulatory writers when applying for FDA approval? Here's how you can ensure high-quality CMC documentation for FDA compliance with clear, precise CMC writing. When scientists adjust their style for regulatory standards, it can make all the difference in achieving approval on time. Discover how to boost your regulatory writing: https://bit.ly/4fQlWrK #CMC #Pharma #RegulatoryCompliance #FDAapproval #FDAstandards
-
-
Ensuring your CMC (Chemistry, Manufacturing, and Controls) documentation aligns with regulatory standards is a key step in achieving FDA approval. For scientists new to CMC, it’s easy to overlook essential FDA guidelines or miss the connection between technical and analytical writing, and the need of a regulatory writing style that's clear and comprehensible to all reviewers. ???? Learn more about LGM Pharma's approach navigating the complexities of CMC writing to streamline your path to regulatory success. Read It Here: https://bit.ly/4fQlWrK hashtag#Pharma hashtag#CMC hashtag#FDA hashtag#RegulatoryCompliance hashtag#PharmaContracting
-
-
?? When N-Zyme Biomedical Inc. approached us to serve as their outsourcing CDMO partner to develop the world's first pepsin inhibitor for Reflux Disease, we knew it aligned with our brand's experience in not just developing drug products, but bringing them to market without compromising speed and quality. LGM Pharma is proud to create a new prolonged-release formulation that addresses the challenges of medication delivery to the esophagus- one of the reasons current therapies for GERD and Laryngopharyngeal Reflux fail. ?? This groundbreaking collaboration aims to deliver the first-in-class treatment of its kind for those battling LPR and persistent GERD symptoms. Learn more about this innovative drug development: https://bit.ly/4eE7lyq #GERDRelief #InnovationInHealth #RefluxDisease #CDMOs #CDMOPartner #MedicalTreatments
-
?? ?? We are proud to announce alongside N-Zyme Biomedical Inc. that we are developing the World's First Pepsin Inhibitor for Reflux Disease—an innovative treatment option aimed at tackling acid reflux at its core. ???? Sometimes, even existing treatments aren’t enough. New solutions are needed to address chronic symptoms of GERD and Laryngopharyngeal Reflux (LPR). We're committed to developing customer-centric solutions in clinical care and addressing unmet needs in the #pharma industry. We're honored to be the outsourcing CDMO partner with #NZymeBiomedical, as it marks an exciting step forward for Reflux Disease patients. Learn more about this innovative drug development: https://bit.ly/4eE7lyq #GERDRelief #InnovationInHealth #RefluxDisease #CDMOs #CDMOPartner #MedicalTreatments
-
?? Something big is on the horizon! ?? As GERD Awareness Week approaches, we’re thrilled to share a sneak peek of an exciting development in our mission to bring customer-centric solutions that reduce risk, increase efficiency, and accelerate time-to-market. Our clients trust us to hit every manufacturing milestone and together with our valued partners, we are dedicated to advancing first-in-class therapies that aim to address unmet needs in gastroesophageal health. Stay tuned for an official announcement during GERD Awareness Week as we take a major step toward providing new hope and relief for GERD sufferers. ???? #GERDAwarenessWeek #GERDRelief #InnovationInHealth #LifeSciences #PharmaDevelopment #CDMO #CDMOPartner
-
November 17-23 is #GERDAwarenessWeek ??? Did you know that laryngopharyngeal reflux (LPR) is a common misdiagnosis for GERD, affecting 20% of Americans? With an estimated 40-50% of GERD patients still experiencing symptoms despite medical treatments and LPR patients having no current therapies available, how do we address this major #pharma need? Keep following along for #GERDWeek to learn more about customer-centric solutions. #PharmaManufacturing #CDMOs #CDMOPartner #CustomerSolutions
-
#GERDAwarenessWeek is coming soon! ??Have you ever heard of Laryngopharyngeal Reflux (LPR)??? It's commonly misdiagnosed for GERD (heartburn anyone?) and affects around 20% of Americans. The danger with this is that LPR currently lacks effective medical therapy for patients. Symptoms of LPR with no relief can contribute to life-threatening illnesses- creating a major need for drug development and therapies to bring effective treatments to market. With modern technology and innovative drug developments on the horizon, we've got our ?? eyes on the future of LPR treatments. #GERDRelief #LGMPharma #FutureOfHealth #CDMO #APIs #CDMOPartner