DSA Consultants

Avrio Biopharmaceuticals is dedicated to providing our clients with high quality, flexible and on time clinical trial material manufacturing services. Our experienced and dedicated staff and our world class facility allow us to provide our clients with timely solutions to meet the demand of early phase clinical trial material manufacturing.

Our newly commissioned, cGMP manufacturing facility offers a full range of services for your clinical trial material production.

Range of cGMP Support Services
Pre-formulation and Formulation Development
Small Molecules
Biopharmaceuticals

Parenteral Fill and Finish Manufacturing
Lyophilization
Blinding and Over-encapsulation
Packaging and Labeling
Regulatory Document Preparation
CMC Support
Clinical Supply Management
Complete Clinical Trial Support
Strategic Clinical Program Management
Clinical Protocol Development
Investigator Recruitment and Qualification
Clinical Study Management, Trial Monitoring and Data Analysis Preparation of Final Regulatory Submissions

BioChroma Analytical Labs LLC is based out of the DFW metroplex in the heart of Texas. It was created to fill the technical gaps in new product development for innovators with new ideas that might not have all the necessary components to make it happen and to offer support for product quality through analytical testing and consulting. We provide an all-encompassing service to help our clients develop a product that is continually manufactured to the level of quality customers expect. Our goal is to provide continual scientific and technical support for entrepreneurs and established businesses based on quality at an affordable price. We are here to provide technical assistance to foster their idea from inception to the marketplace and beyond.
We have experience and expertise in research and development, formulations, scale-up, testing, quality and regulatory of a wide variety of consumer products in the areas of cosmetics, skin care, topical and oral OTCs, food, beverages, dietary supplements, household cleaners and the like.

Product Research and Development: Skin, Body, Hair Care Development, Dietary Supplement Development

Consulting: Packaging Advice, Manufacturing Advice, Plant Inspections, Ingredient Stability Advice, Container Closure Advice, Product Formulation Advice, Quality and Regulatory Advice

Chemistry Analysis: Nutritional Analysis, Mineral Analysis, Vitamin Analysis, Preservative Analysis, Active Ingredient Analysis, Allergen Analysis

Microbiological Analysis: General Microbiology Analysis, Pathogenic Bacteria Analysis, Spoilage Organism Analysis, Preservative Efficacy Analysis, Bacterial Challenge Studies, In vitro Time-Kill Studies, Antibiotic Studies, Water Suitability Testing

Laboratory Research and Development: Transdermal Studies, Antimicrobial Efficacy, Product Specific Studies Aimed at Demonstrating Efficacy or Quality

IRISYS, LLC. founded in 1996, has grown from a small laboratory focused on formulation development to an organization that provides a full spectrum of pharmaceutical product development contract services designed to move compounds from early research to Phase I/II clinical trials. Recro® acquired IriSys in August 2021.
Recro® is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of small molecule therapeutic dosage forms. With expertise in solving complex manufacturing problems, Recro is a leading CDMO providing primarily small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, high potency compound development, packaging, and logistics services to the global pharmaceutical market. In addition to our experience handling DEA controlled substances and developing and manufacturing modified release dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, totaling 145,000 square feet, in Gainesville, Georgia, and San Diego, California.

Lifecore Biomedical partners with pharmaceutical and biotech companies to manufacturer difficult to formulate and fill injectable drug products for clinical trials and commercial production that help improve patient lives. Our expertise stems from decades of experience manufacturing highly viscous pharmaceutical grade sodium hyaluronate.

Lifecore Biomedical is the global leader in manufacturing and supplying sodium hyaluronate (NaHy) for highly viscous injectable drug products. Over the past 30 years, more than 90 million patients have benefited from our certified pharmaceutical grade NaHy. Now we are using our expertise to expand our contract development and manufacturing services to solve the most complex drug development challenges.

Development
• Formulation and Process Development
• Analytical Method Development
• Stability Testing
• Technology Transfer
• Equipment Design and Procurement
• Pilot Batch Sizes for Syringe and Vial Configurations
• Quality Systems Experience in Pharmaceutical and Medical Device Regulations
• Regulatory Support

Clinical and Commercial Manufacturing
• Formulation
• Sterile Filtration of Highly Viscous Solutions
• Aseptic Filling into Syringes or Vials
• Secondary Sterilization
• Final Packaging
• Global Supply Chain Management
• Large, Efficient Batch Sizes

Pharmaceutical and Research Grade Sodium Hyaluronate
• Hyaluronan is a physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and humans.
• Lifecore’s sodium hyaluronate is produced by an efficient microbial fermentation and purified by a highly effective purification process. It is produced in large batches to promote consistency in supply and customer convenience.
• Pharmaceutical grade sodium hyaluronate is available as a powder in a broad range of molecular weights for use in various medical applications (150KDa – 1.8MDa). Sterile pharmaceutical grade sodium hyaluronate is available in select molecular weights.
• Primary medical applications include: Ophthalmology, Orthopedics, Aesthetics, Tissue Engineering, and Veterinary Medicine

Our robust Quality System has been forged from our extensive experience with producing drugs and medical devices for a diverse group of partners over the last 25 years. We continue to learn from our industry partners and global regulatory authority audits to improve and implement best practices in our Quality System.

The Lifecore facilities are US FDA Drug and Device Registered and have GMP (EU, Japan, and Brazil) and EN ISO 13485 certifications. Our facilities are conveniently located in the central United States just outside of Minneapolis, Minnesota.

NHK Laboratories, Inc. is an NPA/NSF GMP, ISO 9001:2008, CCOF and QAI Organic, and ISNA Halal certified custom formulator, contract manufacturer, and contract packager of private label vitamins, minerals, dietary supplements, herbal supplements, nutritional supplements, nutraceuticals, functional foods, and pharmaceuticals.

We operate two facilities in Santa Fe Springs, California that meet or exceed FDA CGMPs. Both facilities have been certified with “A” ratings under the NPA (formerly NNFA) Good Manufacturing Practices (NPA GMP) program since 2001, the NSF GMP Registration since 2004 and is ISO 9001:2008 registered. We are also CCOF and QAI Organic, and ISNA Halal certified. The NPA GMP and NSF GMP programs require an independent audit of our facilities, procedures, training, sanitation and personnel. NPA and NSF GMP requirements are regulatory requirements that provide guidelines for necessary processes, procedures and documentation to assure the product produced has the identity, strength, composition, quality and purity it is represented to possess.

For more information on our manufacturing and packaging services, please call us toll-free at 1-866-NHKLABS.