Bring your idea
We will show you the way
OUr Services
End-to-end Pharma CMC management and consuling services, from idea to market.
We bring vast experience in all types of drug substances, small molecules, peptides and biologics and their formulation in almost any dosage form available, e.g. paretral, oral, topical and liposomal. Our team provides close escort through all stages of development. With strong experience in regulatory writing and submission, we lead our costumers all the way to market.
Project Management
API sourcing and manufacturing
We work with a large veriaty CROs that offer custom made API manufacturing (Small molecules, peptides and biologics). We provide project management and consultancy on manufacturing process, analytics and specification settings, as well as audits to manufacturing sites.
Analytical development
We provide consultancy on analytical methods required for DS and DP and offer support in from the initial development of the methods to full method validation.
Regulatory
We work with top of the line third party regulatory consultants to establish the correct strategy for all stages of regulatory submissions (e.g. IND, IMPD, BLA, NDA)
Formulation Development
We provide project management and consultation on formulation development, reccomended excipients to use based on the nature of tha active material and the desired dosage form.
Process development
We provide project management for process development from samll scale R&D batches, to pilot GMP batches for clinical use up to large scale process development for marketing use. Experienced in non sterile (oral and topical) and sterile manufacturing (fill and finish, liposomal and biologics). Our team is highly experienced with process development as according to QbD using Design of Experiments (DoE) approach
Regulatory submission support
Support writing of all CMC required documents for regulatory submissions and meetings with regulatory agencies
We provide full project management of outsourced CMC activities; from CDMO selection, development planning, definition of quality attributes and control strategy and weekly follow up meetings with the CDMO
Management
Dr. Gadi Sarfati, PhD
Pharma & CMC consultant
With more than 18 years in the Pharma industry, Dr. Sarfati brings with him vast experience in CMC development of pharmaceutical products; from early stage formulation development, through process development and scale up for clinical phases up to large scale manufacturing for market. Expert in different types of dosage forms e.g. oral, parenteral, liposomal, topical and ocular. Dr. Sarfati have managed the R&D and CMC development of more than 15 products, from early stage to products under clinical stages and up to marketing. Involved of regulatory submissions for FDA and EMEA. Dr. Sarfati held senior management roles in research and development, manufacturing, project management and pre-clinical development in multiple regulated industries.
Among our Clients
