LORENZ Partners

Advyzom is a leading boutique consulting company specializing in strategic regulatory and development advice, medical writing, and submission and publishing services across therapeutic areas for our partners in the pharmaceutical and healthcare industry. Our experienced regulatory strategy team integrate seamlessly into product teams, advising senior management and mentoring staff, interact with FDA Divisions and build global development programs. Advyzom’s medical writing experts author a broad range of clinical and nonclinical documents. Advyzom’s Regulatory Operations team provides document and submission publishing utilizing state-of-the-art validated eCTD software for IND’s, NDA/BLA’s, advertisement and promotional materials (OPDP), Veterinary (CVM) e-Submitter submissions via an approved FDA gateway.

Contact:
Telephone: +1 973-687-9849
Email: cdinella@advyzom.com
Web: www.advyzom.com

Aleon Pharma International, Inc. offers extraordinary regulatory consulting and clinical development solutions specifically tailored to each client’s individual requirements in pharmaceutical and biotech product development.

We are Dedicated for Approval®.

Contact:
Telephone: +1 973-850-5300
Email: info@aleonpharma.com
Web: www.aleonpharma.com

APC Instytut is the leader among companies that provide complex services for the Polish pharmaceutical market: Rx, OTC and Medical Devices. Since 1996, APC Instytut has been co-operating with national and international pharmaceutical companies. APC provides professional consulting services in the following areas: regulatory affairs (medicines, medical devices, food supplements, cosmetics); marketing management; outsourcing of medical representatives; recruitment and training.

Contact:
Telephone: +48 22 668 68 23
Email: apc@apcinstytut.pl
Web: http://www.apcinstytut.pl

ARAC AT REGULATORY AFFAIRS CONSULTING GMBH is a team of experts specializing in the marketing authorisation of medicinal products, eCTD, pricing and reimbursement strategies, and pharmacovigilance. The company is based in Vienna, near the centre of the city. The company offers the following services: (1) Marketing authorisation: Marketing authorisation of medicinal products in the EU (2) eCTD: Preparation/reformatting of the registration dossier (3) Pricing strategies: Evaluation of pricing strategies for Austrian market (4) Reimbursement applications: Inclusion in the Code of Reimbursement (5) Pharmacovigilance: Taking over of pharmacovigilance activities (6) MedDRA: MedDRA coding for pharmacovigilance and PSURs.

Contact:
Telephone: +43 1 524 05 89
Email: office@aracgmbh.com
Web: http://www.aracgmbh.com

Allucent is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients since 1988. Allucent has played a significant role in over 50 successful marketing applications. Our highly talented and experienced international team offers services from preclinical through IND (or equivalent), clinical development, and marketing approvals to Phase 4 postmarketing research. Contact our experts to learn more!

Contact:
Telephone: +1 919-361-2286
Web: www.allucent.com

CCS Associates, Inc. is a full service CRO providing scientific product discovery and development services to the Government and private sector pharmaceutical and biotech clients for over 30 years. We are experienced in Regulatory Affairs (eCTD ready submission), Bioinformatics and Data Management, Clinical Trial Management and Early Development, Scientific and Medical Writing, Pharmacovigilance and Strategic Planning, within the United States and internationally.

Contact:
Telephone: +1 650-691-4400
Email: info@ccsainc.com
Web: www.ccsainc.com

Digital Media System Co., Ltd (DMS) provides and supports docuBridge to focus on Japanese market.

Contact:
Web: https://www.dms-jp.com/en/index.asp

Dr. Regenold GmbH is specialised in national and international regulatory affairs. Founded in 1994, Dr. Regenold GmbH has its main office in Germany and joint venture partners in the UK to cover the UK and Ireland and Croatia for South East Europe. In addition Dr. Regenold founded and leads regulanet®, a network of regulatory affairs consultancies with members in over 80 countries throughout the world. Established in 2001, member companies offer services to a wide variety of national and international healthcare and pharmaceutical clients, helping them understand the complexities of the different regulatory requirements and providing solutions. The core service of Dr. Regenold GmbH is regulatory affairs specialising in several product categories from prescription medicines, OTCs, medical devices through to feedback and demand, the services have now been expanded to include Market Access, Portfolio Analysis and Life Cycle Management food supplements. Building upon this and in response to client. By gaining an understanding of clients’ commercial needs, the key decision makers and route to market, Dr. Regenold GmbH is able to recommend regulatory and market access solutions which help clients bring their products efficiently to market and maximise value from their asset. Dr. Regenold GmbH is therefore a 'one stop shop' for national and international regulatory affairs, strategic advice and implementation.

Contact:
Telephone: +49 7632 82 26-0
Email: info@regenold.com
Web: http://www.regenold.com

Eisinger Submission Management is a full service provider for electronic submissions:

• planning, compilation, publishing, submitting, life cycle management of eCTDs and NeeS
• e-Readyness for documents and dossiers
• Regulatory Affairs Consulting: eCTD, Clinical Trials, Medical Devices

Contact:
Telephone: +43 699 17 42 52 66
Email: kurt@eisingersubmissions.com
Web: http://www.eisingersubmissions.com

Exalon supports pharmaceutical companies and CROs in the coordination, compilation and submission of eCTDs and paper dossiers. Exalon has an extensive track history of successful eCTD (lifecycle) submissions in EU as well as US, Canada and other regions. The staff combines regulatory, reg. operations and IT competence; the services range from pre-submission document processing to complete regulatory operation management, training and consulting.

Contact:
Telephone: +49(0)7732-9391650
Email: info@exalon.com
Web: http://www.exalon.com

e-Submissions Solutions provides EDMS and Submission Publishing services.

Contact:
Email: AAzevedo@e-SubmissionsSolutions.com
Web: http://www.e-submissionssolutions.com/

Factorytalk Co., Ltd. is a leading provider of Quality Management (eQMS), Batch Recording (eBR), and eSubmissions (eCTD) software as well as GMP, CSV, & DI compliance consulting services. Factorytalk is LORENZ Life Sciences Group e-Regulatory solutions distributor in Thailand.

Contact:
Telephone: +66 2 630 4525
Email: contact@factory-talk.com
Web: https://factory-talk.com/

ICON Plc offers a full range of consulting, development and commercialisation services from a global network of offices in 37 countries.

Contact:
Telephone: +353 (1) 291 2000
Email: https://www.iconplc.com/contact
Web: https://www.iconplc.com

Innomar Strategies, a part of AmerisourceBergen, is the leading patient support provider in the Canadian specialty biopharmaceutical market. We deliver end-to-end commercialization solutions to improve product access, increase supply chain efficiency and enhance patient care. Strategic consulting, patient support programs, nursing and clinical services, and specialty pharmacy and logistics are just a few of our key areas of specialization. We partner closely with manufacturers, healthcare providers, pharmacies and payers to ensure patients have consistent and reliable access to specialty medication. With our integrated approach and commitment to best-in-class care, Innomar Strategies helps navigate the patient journey to optimize health outcomes.

Contact:
Telephone: +1-888-420-5457
Email: marketing@innomar-strategies.com
Web: www.innomar-strategies.com

InvoFarma is a company created in 2008 with the aim to offer a cost-efficient solution in regards with consultancy and services related to Regulatory Affairs. Based in Barcelona and specialized in services concerning medical writing, registration dossiers compilation and any other related activities as well as document management.

InvoFarma is the LORENZ Life Sciences partner in Spain, Italy and Portugal offering training and outsourcing services related to eSubmissions.

Contact:
Telephone: +34 93 390 51 45
Email: info@invofarma.com
Web: http://www.invofarma.com

IWA Consulting Team has specialized in assisting our clients from development to launch and life cycle management of pharmaceuticals and medical devices. We have a long term and hands on experience in eCTD compiling and support for all regions: EU, US, Canada, Switzerland and others The IWA Consulting Team can advise and assist you all the way through the eCTD processes also if your plan is simultaneous registration in the US and EU. We help you realize profit margins, be competitive and deliver on schedule – every time.

Contact:
Telephone: +45 5666 0490
Email: info@iwaconsulting.dk
Web: www.iwaconsulting.dk

MK Consulting works in the areas of Pharmaceutical Training and Regulatory Affairs Consultancy in Turkey. Regarding Pharmaceutical Training Activities, MK organizes seminars, workshops and conferences about Patents, Pharmaceutical Technology, National and International Pharmaceutical Regulations, Formulation Development, cGMP, Stability etc. Regarding Regulatory Affairs Consultancy, MK provides support to their clients in all kinds of registration related processes of Pharmaceuticals, OTCs, Medical Devices, Cosmetics and Food Supplements such as preparation of dossiers, submissions, national pharmaceutical registration procedures, pricing & reimbursement and other registration related services to both national and international clients. MK Consulting is also the distributor of LORENZ software solutions in Turkey.

Contact:
Telephone: +90 212 251 11 66-67
Email: info@mkistanbul.com
Web: http://www.mkistanbul.com

MMS is an award-winning, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named Most Outstanding Global CRO in the 2019 Biotechnology Awards

Contact:
Telephone: +1 734-738-5062
Email: info@mmsholdings.com
Web: www.mmsholdings.com

MRA Regulatory Consultants are a team of experienced and knowledgeable regulatory consultants committed to bringing quality medicines to South Africa. MRA has a clear understanding of the regulatory environment in South Africa, its history, trends, current requirements and policies. MRA Regulatory Consultants are associate members of many of the industry associations and involved in professional capacities affiliated to the professional associations.

Contact:
Telephone: +27 (0)12 803 1039
Email: info@mra-regulatory.com
Web: http://mra-regulatory.com

The NDA Group is an independent consulting organization focused on the strategic and operational aspects of regulatory affairs. NDA strives to bridge the communication gap between the regulators and the regulated - to the ultimate benefit of the patient. NDA makes sure that medicines reach the market and is maintained there without delay. Because the world is waiting.

Contact:
Telephone: +46 (0) 8 410 417 90
Email: london@ndareg.com
Web: http://www.ndareg.com

Pharma To Market is an Australian based company specializing in electronic submissions and regulatory affairs consulting. Pharma To Market are proud to be the Australian market leader offering services specializing in eSubmission software implementation and eSubmissions outsourcing to companies in Australia and New Zealand. Pharma To Market’s partnership with LORENZ Life Sciences Group enables us to offer an unparalleled depth of capabilities including support for LORENZ’s market-leading eSolutions portfolio. We provide full implementation, maintenance and accredited training courses for LORENZ Life Sciences software products including their flagship publishing solution LORENZ docuBridge.

Our team have over 50 years experience in global regulatory affairs. We have been responsible for the preparation and submission of pre and post-approval applications resulting in registrations of pharmaceuticals in key markets including Australia, Europe, USA and Canada. Pharma To Market are able to offer first-hand advice to clients seeking marketing authorizations in these regions.

Pharma To Market’s values include their customer focus. Their relationships with clients are built on trust, transparency and reliability, which Pharma To Market achieves through their commitment to quality and excellence. They go the extra mile to achieve results and fit in with their client’s time frame and budget.

Contact:
Telephone: +61 (0)7 3122 9979
Email: http://www.pharmatomarket.com/contact
Web: http://www.pharmatomarket.com

PharmaLex is now part of Cencora, a leading global pharmaceutical solutions organization centered on improving lives around the world. PharmaLex adds to Cencora's expanding suite of pharma solutions and serves the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle.

Contact:
Email: contact@pharmalex.com
Web: http://www.pharmalex.com

Premier Consulting provides strategic product development and global regulatory consulting services with unparalleled nonclinical, CMC, quality, clinical, and commercial expertise. We offer end-to-end strategic insights to help biotech companies advance their programs through every development milestone, from the earliest stages through commercialization.

Contact:
Telephone: 833-734-2729
Email: services@premierconsulting.com
Web: www.premierconsulting.com

regulanet®, founded by Dr. Regenold, is a network of regulatory affairs consultancies with members throughout the world in more than 90 countries. Led by regenold GmbH, the members offer services to a wide variety of national and international healthcare and pharmaceutical clients. The network uses state-of-the–art tools to ensure efficient communication and access to information, between members and clients. regulanet® provides advice and assistance on national and international projects and marketing authorisation procedures, including the decentralised, mutual recognition and centralised procedures within Europe.

Contact:
Telephone: +49 7632 82 26-0
Email: info@regulanet.com
Web: http://www.regulanet.com

Regxia is a unique scientific and regulatory consulting firm servicing the pharmaceutical and biotech industries. With a primary focus on small and midsized customers, we provide knowledge, experience and innovation to lead your clinical and marketing applications through to FDA and Health Canada approval. Offering a full range of services for products at all stages of development, we provide ePublishing, scientific writing and strategic development.

Contact:
Telephone: +1 416 620 5236
Email: info@regxia.com
Web: http://www.regxia.com

Rho, a privately-held, contract research organization (CRO) based in RTP, NC, provides a full range of services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.

Contact:
Telephone: +1 919 408 8000
Email: Info@rhoworld.com
Web: www.rhoworld.com

As an oncology CRO (contract research organization) dedicated to precision medicine, Translational Drug Development (TD2) works with innovative biotech and pharma companies to bring cancer treatments to patients as quickly as possible. In our 15 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

Contact:
Telephone: +1 602-358-8300
Email: nmartinez@td2inc.com
Web: www.td2inc.com

Triangle Regulatory Publishing, LLC (TRP) is a full-service Regulatory Operations company. Our dedicated team of experts assist clients with successfully navigating the electronic Common Technical Document (eCTD) standards and requirements of the various Regulatory Authorities. We gracefully manage every detail and deadline using leading industry publishing systems and tools.

Contact:
Telephone: +1 919-886-4587
Email: Info@TriRegPub.com
Web: www.TriRegPub.com

VECTOR Life Sciences focuses on Regulatory Operations for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. VECTOR supports both industry and regulators in their transition from paper based methods to electronic processes. VECTOR distributes and implements LORENZ e-Regulatory solutions in South Africa.

Contact:
Telephone: +27 12 803 4444
Email: info@vectorls.co.za
Web: http://www.vectorls.co.za

WAYS Pharmaceutical Services delivers expert regulatory submission management services to life sciences teams that are preparing for or maintaining electronic regulatory submissions supporting drug, biologic, and medical device trials and marketing applications. The WAYS team combines collaboration, innovation, and commitment to provide quality electronic submissions and an unparalleled customer experience. No drama and no trauma - just solid expertise delivered where and when you need it.

Contact:
Email: servicepartner@waysps.com
Web: www.waysps.com