Clinical & Regulatory Strategic Consulting Archives - MassBio

Boston Biodevelopment LLC

wpengine — Wed, 25 Oct 2023 14:34:30 +0000

Boston Biodevelopment is a premium boutique regulatory strategy consulting firm of highly experienced regulatory professionals, including former heads of regulatory, providing world-class hands-on regulatory leadership and management to small and mid-size life sciences companies throughout the development and approval of new therapies.

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G&L Healthcare Advisors

wpengine — Tue, 14 Nov 2023 10:02:04 +0000

G&L’s management team has decades of experience in Regulatory Affairs and Quality Assurance, successfully tackling some of the most technically challenging projects to deliver exceptional value to clients from commercial and scientific standpoints.

The company has proven success in working directly with local authorities in established and emerging markets around the world on behalf of clients, with their most senior colleagues having in excess of 35 years’ global experience.

This exposure to different regulations and agency nuances and cultures has proven to be of great benefit to G&L’s clients.

The company has a genuinely multi-national presence, spanning over 100 markets globally.

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Orphan Drug Consulting

wpengine — Tue, 03 Oct 2023 11:32:08 +0000

Orphan Drug Consulting supports new and emerging pharmaceutical/biotech companies define and implement their global product supply strategy to launch in new markets. We offer end-to-end support as you navigate your way through legislation across supply chain, quality assurance, regulatory, entity planning, tax and customs rules to support your business in launching as quickly and smoothly as possible.

Orphan Drug Consulting brings many years of supply chain and quality assurance experience to assist your organisation in bringing a product from clinical to commercial launch, specialising in Orphan Drug/virtual launch.

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RQMIS, Inc.

wpengine — Fri, 15 Sep 2023 09:32:28 +0000

RQMIS is a comprehensive regulatory consulting firm, focused on bringing our clients’ products to market in the most time and cost-efficient manner possible. Whether you’re looking to bring your product to the EU, US, UK, Latin America, or anywhere else in the world – we can help. We specialize in four principle areas: Regulatory Strategy and Submissions, Clinical Study Design and Management, Quality Systems Design and Compliance, and Medical Insurance Reimbursement. We also offer a wide range of administrative services including Registration & Listing, Small Business Certification, Authorized Representative services and much more!

Our consulting firm has over 45 years of experience servicing domestic and international clientele. We have been fortunate to work with a wide variety of clients with products ranging from medical devices, combination products, pharmaceuticals, supplements, nutraceuticals and more. Our multi-disciplined, innovative group of subject matter experts (including former FDA reviewers) offer a unique combination of talent and experience, consisting of key personnel working together to get your product compliant and on the market.

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SciLucent

wpengine — Wed, 08 Nov 2023 10:02:36 +0000

SciLucent provides regulatory, scientific, and project management services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, medical devices, combination products, and dietary supplement ingredients. Since 1998, our multidisciplinary team works closely with our clients to identify and manage activities and issues that impact product development, manufacturing, quality, safety, regulation, and marketing.

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Syner-G BioPharma Group

wpengine — Wed, 01 Nov 2023 15:01:18 +0000

Syner-G BioPharma Group provides in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development, and Quality/IT. We call this CMC 360™. We also provide medical writing services, with expertise in authoring a variety of regulatory documents across a wide range of therapeutic areas and in all phases of development. Our regulatory affairs services include the development and implementation of global regulatory strategic plans, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. We have the skill set and experience to guide your prime asset through any development challenges and along the ever-changing maze of regulatory filing pathways, to a position of full compliance, and high quality. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.

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Voisin Consulting, Inc.

wpengine — Fri, 08 Dec 2023 01:02:05 +0000

Voisin Consulting assists biotechnology, pharmaceutical and medical technology companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development. Products include drugs, biologics, medical devices, combination products, advanced therapy products, as well as borderline products (food supplements and cosmeceuticals). Voisin Consulting collaborates with start-ups and medium-size companies to bring products to the market in the most efficient and cost effective manner, within an evolving regulatory framework. Voisin Consulting has offices in Cambridge, MA, France, Switzerland, India and the United Kingdom.

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