Development
Emkam Pharma is a leading Contract Development and Manufacturing Organization (CDMO) offering a wide range of services to the Small Molecules and Biologics industry. Our client base includes small and medium-sized BioPharma companies as well as large global BioPharma organizations.
With our expertise and experience, Emkam Pharma provides comprehensive preclinical and clinical development services for both small molecules and biologics. We support our clients throughout the drug development process, from lead generation to clinical supplies of drug substances and drug products. Our clinical development services encompass Phase I, II, and III trials, and we assist our clients in drug filing with regulatory authorities such as the FDA and other global regulatory bodies.
What distinguishes our Development services is our full-service capability and well-rounded expertise, enabling seamless integration of R&D programs and accelerating the time to market for our clients’ products.
Our Development Services include a wide range of offerings, such as Chemical Process Design, Development, and Optimization, Oligonucleotide Synthesis, Performance & Specialty Materials, Pre-Formulation, Toxicology Formulation, Formulation Development, Analytical Development, Stability Services, Clinical Development, Human Pharmacology Unit – BA/BE studies, Bioanalytical Services, Clinical Trial Management, Medical Writing and Monitoring, Regulatory Services, Biometrics and Clinical Data Management, Clinical Trial Supply for finished products (FDF), High Potency API Manufacturing, and Late Stage API Commercial Supply.
In the field of Biologics, we work with diverse biological entities, including Monoclonal Antibodies, Antibody Fragments, Recombinant Proteins, Glycoproteins, Pegylated Proteins, Subunit Protein Vaccines, mRNA, microbial (E. coli and Pichia), microbiome Live Biotherapeutic Products, and Multimeric Protein Complexes. Our services encompass Cell Line Development, Developability Assessment, Process Development, Viral Reduction Steps and Clearance Studies, Product Characterization, Bioassays, Stability Studies, Formulation Screening, Drug Substance (Upstream and Downstream Processing – Mammalian, Microbial), Drug Product – Clinical Supplies, ready-to-use vials/PFS, Analytical Method Transfer, Analytical Method Validation, Viral Testing and Clearance Services, and Bioanalytical Laboratory Services.
Our Development Services can be availed as stand-alone offerings or as part of integrated activity bundles. We also provide customized solutions tailored to meet the specific requirements of our clients’ R&D programs. Our team of scientists possesses cross-functional, multi-disciplinary expertise, allowing us to seamlessly implement integrated programs. With a proven track record, we have successfully managed and executed projects of diverse complexities for a global clientele, resulting in over 400 patents held with our clients to date.
Emkam Pharma is committed to being your trusted partner, supporting you at every stage of the development journey and helping you bring innovative therapies to market efficiently and effectively.