A manufacturing program depends on many specialists. The formulation scientist understands formulation. The validation engineer understands validation. The packaging lead understands packaging. But someone still has to connect those decisions, identify dependencies and keep the program moving.
Eastern GMP Consulting, LLC is set up for that role. Founded in 2020 and based in North Wales, Pennsylvania, the independent pharmaceutical and biotechnology consultancy is led by Scott Del Tito, who brings 30 years of industry experience across technical operations, CMC project leadership and senior process validation roles at large pharmaceutical organizations. He has completed more than 25 technology transfers, qualified more than 50 CDMOs and led more than 100 validation campaigns. The firm primarily advises sponsors, helping drug developers select, qualify and manage outsourced partners. Eastern GMP Consulting is a Founding Partner on CDMO Hub, where buyers can review its services and verification status.
Why breadth matters
Specialist expertise is often organised by function. What can be harder to find is one technical lead who understands development, transfer, validation, packaging and supply, and can see how a decision in one area affects another. Many program risks emerge at the handoffs between functions or from assumptions that have not been tested.
Five recurring challenges show where Eastern GMP Consulting's capabilities can support a sponsor.
1 Choosing a vendor before the program is fully defined
Vendor selection often begins while the process is still evolving and the commercial requirements remain uncertain. A CDMO that fits a Phase 1 campaign may not be the right partner for process validation or commercial supply. Sponsors therefore need to know what to ask, what evidence to review and which expectations to document before an agreement is signed.
Eastern GMP Consulting offers CMC vendor management from preclinical development through commercial supply. Its scope includes vendor selection, qualification and ongoing management of the relationship after the contract is signed.
2 Keeping technology transfer on track
Technology transfer is a common point at which timelines come under pressure. Documentation may be incomplete, or differences in equipment and working practices may lead the receiving site to interpret the process differently from the sending site. Addressing these gaps requires practical transfer experience as well as complete documentation.
Eastern GMP Consulting lists product technology transfer as a core service for both small molecules and biologics. Its stated expertise covers process scale-up, granulation, tablet compression, coating and continuous manufacturing for oral solid dosage forms, as well as downstream processing, chromatography, ultrafiltration and biologics manufacturing. This breadth allows sponsors to coordinate different transfer requirements through one consultancy.
3 Building validation that is inspection ready
Equipment, process and packaging validation can sit on the critical path to approval and receive close attention during regulatory inspections. An experienced validation lead can identify gaps earlier and help ensure that the strategy is practical, documented and ready for inspection.
Eastern GMP Consulting provides process and packaging validation, equipment-selection support, and regulatory and quality compliance support. This allows the validation strategy and inspection-readiness work to be considered as parts of the same program.
4 Bringing packaging and serialization into the plan
Packaging and serialization are sometimes addressed too late, even though they can become important drivers of launch timelines. Artwork, serialization integration and packaging validation each have their own lead times and depend on manufacturing decisions made earlier in development.
Eastern GMP Consulting covers clinical and commercial packaging, together with packaging and serialization expertise, within the same technical scope as manufacturing and validation. This helps sponsors account for packaging requirements earlier rather than treating them as a separate, late-stage activity.
5 Maintaining technical continuity after launch
After approval, a sponsor still needs supply-chain oversight, technical support at the CDMO, and effective management of changes, deviations and second-source planning. Maintaining technical ownership across the launch boundary can be particularly important for organizations with lean internal teams.
Eastern GMP Consulting lists supply-chain management and post-launch technical services within its scope. For a small or mid-sized sponsor without a permanent technical operations function, this can provide continuity from development into routine commercial supply.
Who the consultancy is suited to
Eastern GMP Consulting is suited to sponsors that need experienced technical leadership across CMC and outsourced manufacturing rather than separate support for each individual function. Its listed scope runs from vendor selection through technology transfer, validation, packaging, serialization and post-launch supply for both small molecules and biologics.
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