Bioserv Corporation

I manage the Drug Product Manufacturing and Discovery Biology for Archer CPS. I serve multiple roles in Archer’s drug discovery, manufacturing and analytical work. My experience ranges from industrial to academic to non-profit environments, working in several fields including Chemistry, Biochemistry, Structural Biology and Drug Formulation. I have developed several immediate and modified release formulations of novel therapeutics and has completed Phase I manufacture of drug product in support of regulatory filings for Archer. I am actively engaged in collaborative efforts with Archer biologists to screen and validate novel drug compounds and targets in addition to overseeing drug formulation, manufacture, and analysis. I have developed many methods for small molecule isolation and characterization for drug discovery, as well as conventional quality control tests required for drug substance and drug product release and stability. I work closely with Archer CPS's Quality Services group in the preparation of the CMC sections for IND and IMPD submissions.

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

Thermo Fisher Scientific provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers through our Patheon brand. With more than 65 locations around the world, we provide integrated, end-to-end capabilities across all phases of development, including API, biologics, viral vectors, cGMP plasmids, formulation, clinical trials solutions, logistics services and commercial manufacturing and packaging. Built on a reputation for scientific and technical excellence, we provide pharma and biotech companies of all sizes instant access to a global network of facilities and experts across the Americas, Europe, Asia and Australia. We offer integrated drug development and clinical services tailored to fit your drug development journey through our Quick to CareTM program. Our Quick to ClinicTM programs for large and small molecules help you balance speed and risk during early development so you can file your IND quickly and successfully. Digital innovations such as our mysupply Platform and Pharma 4.0 enablement offer real-time data and a streamlined experience. Together with our customers, we’re rapidly turning pharmaceutical possibilities into realities.

Idifarma is a Contract Development and Manufacturing Organization (CDMO) for small molecule oral drug development and manufacturing, with high potency and spray drying capabilities.

Idifarma is part of Ardena, your one-source partner to help you navigate the drug development process from molecule to clinic.

Ardena is a pharmaceutical CDMO that guides companies through the drug discovery and development process to help create effective and compliant drug substance and products for clinical trials.

Ardena provides you with an integrated service offering including solid state chemistry, API & nanomedicines development and manufacturing, analytical & formulation development, drug product manufacturing, bioanalytical, drug discovery and dossier development services.

Headquartered in Ghent, we have facilities in the Netherlands, Belgium, Sweden Latvia and Spain, serving a global customer base, ranging from emerging biotech to tier-one pharmaceutical companies.

We understand the complex challenges involved in taking a promising molecule from lab to patient.
Each project we undertake is preceded by a detailed planning phase to ensure that the right work is carried out at the right time. This staged approach allows you to stagger your investments and mitigate risks during each phase of the project.

Our integrated offering is the engine that drives all of our projects. Our multidisciplinary team is keen to streamline your development process.

We also make sure that all the work we do for you is compliant with the appropriate regulatory standards as you move along the clinical development path. Our dossier-centric approach is key to help you compile your regulatory dossier in a timely and cost-efficient manner. By preparing your regulatory dossier in parallel with drug development, we ultimately get your drug to patients faster.

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.