Generic development and comparative clinical studies depend on materials that can be surprisingly hard to obtain: specific lots of a reference listed drug, comparator products for a trial, or an active ingredient from a qualified manufacturer. Stark Associates helps pharmaceutical companies locate and procure these materials through established supply channels.

Reference listed drugs and comparators

We help identify and source reference listed drugs and comparator products for bioequivalence studies, clinical trials and formulation development. Requests can specify strengths, pack sizes, quantities, required documentation and lot or expiry requirements, and we confirm what the supply chain can realistically deliver before you commit.

APIs and intermediates

For development and commercial programs, we support the search for active pharmaceutical ingredients and intermediates, gather supplier information and available documentation, and coordinate samples and quotations so your team can complete its own supplier qualification.

Documentation and traceability

Every sourcing engagement keeps a clear record of origin, chain of custody and supporting documents, as available from the supplier, so materials can be used with confidence in regulated work.

What we need from you

A clear specification, the intended use, the quantities and timeline, and any documentation or storage requirements. From there we report options, lead times and costs before any order is placed.

How engagements work

Each request is handled as a defined project with a single point of contact. Final supplier qualification and release decisions remain with your quality organization.

When clients call us

Typical requests come from generic development teams starting a bioequivalence program, clinical teams that need comparator supply for a new study, or buyers looking for an alternative API source.

We confirm availability and lead times before you place any order.

If a product is short or restricted, we say so early and suggest practical alternatives.

RLD and comparator sourcing covers

Innovator products
Biosimilars
Complex and small-volume drugs
Controlled drugs
Single or multiple lots with maximum available expiry
Niche and hard-to-find products

API sourcing support

Transfer of new chemical entities, small molecules and biologics
Quality testing of APIs and intermediates
Support with agency filings and questions about API master files
Technology transfer support
Contract negotiation on the client's behalf
Regulatory and strategic advice on global sourcing

Sourcing reference products, comparators and APIs.