OUR APPROACH

Committed to Delivering Exceptional Results.

Alcami starts every project with a collaborative approach that ensures a successful path for any drug product from early-stage development and scale up to integrated manufacturing and commercial success.

Our Approach

It takes a broad community to develop a new medicine. FDA approval represents decades of work by thousands of scientists, disease control specialists, expert advisors, community health workers, funders, and study participants. We operate as a virtual development team, so without the support of our dedicated collaborators such as Alcami, such incredible achievements would not be possible.

Medicines Development for Global Health
Mark Sullivan, Founder and Managing Director, Medicines Development for Global Health

Evaluations & Proposals

Alcami’s collaborative approach starts at the earliest opportunity: at the evaluation stage when RFP development, initial discovery, and dialogue can reveal a drug product’s true potential and set the stage for its future success. We have a proactive technical evaluation team with the experience and resources to tailor a customized proposal for your needs.

Connecting closely with our customers is something we’ve become really good at. Experience has helped Alcami simplify this process and make it easy to structure a singularly effective proposal that has the backbone to support your program’s strategic goals and deliver its therapeutic outcomes.

Project Management

Beginning with a single point of contact, our project managers deliver an experience that combines world-class operations, technical acumen, and management expertise. Timely access and intervention are supported by our highly refined processes and best-in-class quality systems. Alcami integrates program, project, and process in a unique and highly effective way in which a product’s potential is turned into reality day-after-day.

Quality, EH&S, & Compliance

Alcami meets all applicable local, state, and federal regulatory requirements, including current GMPs and country guidelines for the US, Canada, EU, and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP, and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC), and employee safety (OSHA).

Our Commitment

We are committed to building a personalized connection with our customers where we collaborate scientifically and philosophically. This relationship is cultivated from the onset to foster transparency and trust. Alcami connects our customers and partners to the resources and capacity they need to ensure the best possible outcomes for their products at every level.

Community & Social Impact

Alcami is proud to have an established Foundations Team comprised of cross-functional team members from every site in our company. Combining company resources with their own, the team supports charitable and community organizations that advance the health industry, Science, Technology, Engineering, Arts, and Mathematics (STEAM), environmental, and other social initiatives that align with the our mission and values. In addition to direct financial contributions, employees seek to make a difference through strong volunteer partnerships.