BOCA RATON, Fla.–(Business WIRE)–LGM Pharma today introduced the start of its new Analytical Products and services providing that presents analytical screening and balance companies to pharmaceutical developers and brands, together with compounding pharmacies. The enterprise, which currently conducts analytical services as portion of its built-in deal advancement and production (CDMO) functions, now is providing its analytical expert services experience and facilities as a standalone deal service for pharmaceutical sector consumers.
“We are delighted to be capable to offer our to start with-rate analytical and steadiness screening services to the broader neighborhood of drug manufacturers and builders,” stated Shailesh Vengurlekar, Senior Vice President, High-quality & Regulatory Affairs at LGM Pharma. “Our acquisition final yr of Nexgen Pharma’s CDMO company considerably expanded our actual physical infrastructure and our pool of scientific expertise, which includes specialised facilities, tools, and personnel with in depth abilities in analytic and balance testing. As a outcome, we now are in a position to present a entire suite of these providers as a standalone choice.”
Mr. Vengurlekar continued, “Our progressive technique to analytical and steadiness testing focuses on translating our deep knowing of details into actionable success. It is complemented by our capability to craft individualized frameworks for our customer interactions, spanning just one-time tasks, preferred seller interactions, detailed drug advancement and manufacturing partnerships, and all the things in-in between. We welcome both of those new and returning purchasers to understand extra about our Analytical Solutions.”
With a network of CGMP services in California, Colorado, and Texas, condition-of-the-artwork chromatography and spectroscopy machines, and about 60 QA, QC, and analytical staff users, LGM Pharma is nicely-positioned to provide substantial-excellent, precise, customer-precise, and well timed analytical and steadiness testing and reporting for drug substances, excipients, and drug solutions. Its providers consist of in depth analytical system enhancement and validation processes that abide by the maximum benchmarks and meet all CGMP demands and ICH rules. LGM Pharma analyzes samples working with recognized pharmacopoeia strategies and offers in depth, superior-good quality balance companies making use of the company’s on-internet site stability chambers taken care of for every ICH tips. It takes an innovative solution to producing and validating stability-indicating methods for all forms of drug substance and drug product. LGM Pharma also delivers the evidence desired to assistance shelf-daily life promises for Food and drug administration regulatory filings. For a lot more information and facts on the company’s in depth Analytical Services, stop by lgmpharma.com/analytical-services/.
LGM Pharma also declared it will take part in the digital DCAT 7 days, July 12-16, 2021. CEO Prasad Raje, PhD, will talk about the company’s transformational integration of the CDMO company of Nexgen Pharma, which it obtained in July 2020. That presentation will be obtainable to DCAT users setting up July 12 via the DCAT member portal. For much more facts, go to https://dcatweek.org/MemberAnnouncementForum.
About LGM Pharma
LGM Pharma is a top CDMO provider of extensive API sourcing and drug item contract advancement and manufacturing alternatives to the pharmaceutical, biotechnology, and compounding pharmacy industries. LGM Pharma assists consumers in taking care of all phases of the drug item development process, from Energetic Pharmaceutical Ingredient (API) sourcing via to commercialization. LGM Pharma’s in depth world community of certified API associates allows customers to improve offer chain administration and distribution. Providers consist of formulation enhancement, analytical strategies growth, methods and process validation, ANDA / NDA item submission, steadiness scientific tests, raw product, and concluded products screening and packaging. LGM Pharma is committed to top quality. It has a prolonged-proven favourable regulatory monitor record and provides expert regulatory and marketplace intelligence products and services to its clientele. The organization is focused on client services and tailored solutions, giving shoppers a extensive, one particular-cease manufacturing solution that lowers hazard, boosts effectiveness, and accelerates the path to commercialization. For a lot more info, check out lgmpharma.com.