CMC product Development Services

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Discovering solutions:

Our team of experts is ready to collaborate with you from the initial stages of drug discovery to manufacturing, post-approval, and life cycle management. We can support projects involving a wide range of drug types, such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs, , protein complexes, recombinant proteins/enzymes, lentivirus/adeno-associated virus gene therapies), peptides, cell therapies, oligonucleotides, and other biologics, including, small molecule drugs as well as novel formats . By working with our scientific consulting teams and regulatory, you can reduce your time to market and achieve successful completion of the entire drug development life cycle, from concept to commercialization and beyond. We offer specialized solutions to address the challenges associated with creating novel production methods and complex products, including novel drug delivery systems (NDDS), compounds with gastric intolerance compounds with bioavailability and permeability issues, poor physical stability, low bioavailability, and brief duration of action (BVA).

We have a track record of successfully projects progressing drug discovery for the pharmaceutical industry across a wide range of therapeutic areas. A wide range of drug discovery services are available from our highly skilled and informed team of experts, including discovery biology, discovery chemistry, medicinal and synthetic chemistry, bio analytical services and DMPK/ADME. Biopharmaceutical firms depend on our extensive discovery biology services as we hold the top position in microfluidic technology in the market, possess the largest exclusive collection of peptide substrates, and offer various biochemical testing based on microfluidics. We are extremely delighted about our ability to excel in target-to-hit, hit-to-lead, and lead optimization selection. Additionally, we have a targeted library platform and easy access to starting materials, which enables us to move rapidly from idea to potential candidate.

Development and manufacturing services for drug substances:

Pre-formulation, formulation, and process development services for large- and small-molecule medicinal products:

Our drug product development services are tailored to support the entire drug development process, from scouting and comparing new synthesis pathways to scaling up existing ones, GMP production, and manufacturing both active pharmaceutical ingredients (APIs) and medical device components. Our Kilo lab facility is specifically designed to offer flexible and affordable services to meet program goals, from early research to small-scale commercialization. We also have cGMP capabilities for both small-scale commercial API manufacturing and clinical trial manufacturing. Our experienced staff has a track record of solving the most challenging chemical development problems, providing strategic insights on the manufacturability of medicinal compounds and shortening time-to-market.

Our aim is to help pharmaceutical and biotech companies identify and improve potential synthetic processes for drug discovery, and scale them up to meet production needs., Our formulation scientists at MedWatch Global possess significant expertise in formulating and refining both small and large molecule drugs in a variety of dosage forms for use in pre-clinical studies, clinical trials, and small-scale commercial production. Our emphasis on quality and our ability to address intricate formulation problems with success allows us to hasten the development process and introduce reliable and efficient parenteral, oral, topical, and ophthalmic dosage forms to the market. MedWatch Global is committed to delivering outstanding support, providing drug development services in addition to regulatory and scientific consulting to clients.

Clinical-scale drug product manufacturing services:

  1. Custom Formulation Development
  2. Process Optimization
  3. Scale Up Capabilities
  4. Analytical Method Development