serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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Partnerships

Through our many high quality partnerships, we have been involved in the forefront of product development, analytical testing, manufacturing and contract clinical testing of high quality off-patent pharmaceuticals.

Our Partners


Piramal CRO Clinical Testing
AnaCipherLogoAnaCipher is a new Pharma Analytical Service Division of Indoco Remedies Limited, a fully integrated and research oriented pharmaceutical company with a global presence. This vertical has been carved to serve our customers through analytical research needs, utilizing the state-of-the-art infrastructure and highly experienced human resources.

AnaCipher offers a Complete Integrated Solution having Innovative and Chemistry Based Approach..

Click here to go to AnaCipher website for more information.



clinicalstudyLifecell's LLC stem cell investigational treatment for CLI Our CEO, Paul Sudhakar is involved in the investigational research in a clinical trial using the patient's own stem cells to assess the efficacy and safety of a for patients with advanced Critical Limb Ischemia.PTS Global Services' partner company, Lifecells, LLC specializes in the development of cellular therapies for the treatment of diseases and conditions that impact tens of millions of people worldwide.

Click here to go to Lifecells LLC's website for more information on this breakthrough investigational stem cell treatment for CLI.



Astrum Pharma is a biopharmaceutical company with diverse operations in the pharmaceutical and allied healthcare industries

Astrum Pharma is a biopharmaceutical company with diverse operations in the pharmaceutical and allied healthcare industriesAstrum Pharma is a biopharmaceutical company with diverse operations in the pharmaceutical and allied healthcare industries. Astrum Pharma and its principals have immense scientific, operational, sales & marketing experience in the healthcare industry.

Astrum Pharma Corporations' Vision is to distribute, sell and market cost-effective, branded and generic products, which will satisfy the needs of patients. All our policies are market driven with the customer being the focal point. Astrum is committed to create brand equity by promoting top class products. In order to achieve this Vision, we undertake to create value for all the constituents we serve: our customers, patients and the community.

Astrum Pharma also develops and provides high quality OTC products and nutritional supplements, including THERAFREEZE - Cool Therapy Pain Relief Gel

Click here to go to Astrum Pharma's website for more information.



Midusa-affordable-drugs

Midusa, LLC - affordable pharmaceuticals for developing countriesMidUSA Pharmaceuticals is dedicated to developing, manufacturing, marketing and distributing safe, innovative and cost-effective pharmaceuticals.

Our goal; provide first class global contract pharmaceutical manufacturing, clinical testing, process & plant validation and analytical services, under US FDA current good manufacturing practice (cGMPs) standards, as an assistance to other feeder pharmaceutical and support companies.

Click here to go to MidUSA LLC's website for more information on their work.



Clinsync - Synchronizing and Drug Development

clinsync logoClinSync is a consolidated dream that has come true of a like minded medical doctors dream focused on research, prominent in their respective therapeutic areas with a vision to be a preferred and globally respected research partner for Pharmaceutical, Biotech, Medical Devices and Healthcare IT companies.

With a mission to achieve their vision by conducting the duties in highly ethical environment and providing ClinSync services with honesty, quality and compliance to our clients, stake holders and employees; They advocate the clinicians, researchers and patients in ethical ways to expedite the development of new medicines and/or technologies that alleviate suffering of the patients.

Click here to go to ClinSync's website for more information.



Biomedical Devices of Kansas LLC (BMDK), qualified under FDA QSR

Biomedical Devices of Kansas LLC (BMDK), qualified under FDA QSRBiomedical Devices of Kansas LLC (BMDK), qualified under FDA QSR (21CFR 820) was formed in 2006. Since its formation BMDK has been able to make successful market penetration in the field of medical device design, rapid prototyping, contract manufacture, testing, embedded application development, engineering design, refurbishing and repair.

BMDK houses complete design, fabrication and testing facilities including a laboratory with static-dissipative surfaces and flooring; and ISO environmentally controlled (EC) room for production, an environmental chamber that can handle 5 foot tall assemblies and purified water system for in-process needs.

Click here to go to Biomedical Devices of Kansas' website for more information.



rd2rx-image

rd2rx RD2Rx, LLC is a provider of comprehensive pharmaceutical development services which transition your products from Research and Development phase to the Prescription phase!

Our approach is simple that emphasizes developing and delivery of customized and effective solutions.

Product Development Services, Regulatory Services, Unique Offerings: Your eCTD and SPL Capability, cGMP Services, Marketing Services, Market Research Services and Analysis

Click here to go to RD2RX's website for more information.



Preclinical Services

preclinicspreclinics GmbH is a diverse research organization and service supplier. We are a partner for the development of drugs (small molecules, peptides, biologicals etc.), drug delivery formulations and medical devices, 

Efficacy Assessment and Pharmacokinetics - we are experienced in cardiovascular, inflammatory, orthopedic, hematological and oncological indications in various species to find and establish or develop the suitable test method for your product.

preclinics offers various Research Services for biological and clinical research.

Click here to go to preclinics' website for more information.



neuheit

neuheitNeuheit Pharma Technologies Private Ltd is a Hyderabad based Research & Development Company specialized in the development of drug products.
The company is engaged in the development of complex generic and differentiated products from ideation to commercialization. It also offers consultancy services in all disciplines of pharmaceutical product development including Biostudies.

Click here to go to Neuheit's website for more information.



OWP Pharmaceuticals

OWP PharmaceuticalsOWP Pharmaceuticals delivers quality branded generic epilepsy medications that are replicable and fairly priced. Our strategic focus is to support neurologists and patients in the U.S. with beneficial products and to use the majority of profits to provide resources for those living with epilepsy in under-resourced areas of the world. We do this by partnering with the ROW Foundation to improve the diagnosis and treatment available to these under-resourced patients and their families. This symbiotic relationship enables us to better serve the entire epilepsy community. One World. One Standard.

Click here to go to OWP Pharmaceuticals' website for more information on their services.



validation edge

Validation EdgeValidation Edge, LLC provides support and consultation for the Facility, Utilities and Equipment Qualification, Process Scale-up, Process Validation, Cleaning Validation, Computer System Validation, and Continuous Improvement projects for the Pharmaceutical, Biotechnology, Medical Device, Diagnostic and Active Pharmaceutical Ingredient (API) industries.

Validation Edge, LLC has a proven track record of creating policies, procedures and templates for the commissioning, qualification & validation protocols and final reports.

Click here to go to Validation Edge LLC's website for more information on their services.

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