Services

Product Development

We are specialized in solid & liquid formulation development for both generic & innovative products. Our product development program focuses on modified release solid dosage forms and injectable dosage forms for both small molecule compounds and biologics. We are also specialized in product development strategies for challenging ANDAs such as paragraph IVs as well as 505b2 NDAs for aging product life cycle management.

We can tailor our development program to fit the needs of your drug candidates to provide efficient & timely service to meet your timeline. We will develop robust and stable formulations with required pharmacokinetic characteristics and built-in concept of Quality-by-Design (QbD). We will also develop robust manufacture processes to make sure your products can be manufactured smoothly at commercial scale.

cGMP & compliance

We provide the following cGMP & compliance services, preferably through product collaboration:

  • Manufacturing facility design cGMP concept review
  • Manufacturing equipment selection & qualification
  • QC laboratory set up, including quality control system set up & testing instrument selection & qualification
  • Quality assurance system set up
  • Process validation program design & execution

Regulatory Affairs

We provide the following regulatory services in the US:

  • ANDA submission preparation (eCTD or paper CTD) & filing
  • 505b2 NDA submission preparation (eCTD or paper CTD) & filing
  • ANDA or 505b2 NDA review support & FDA communication
  • Act as a US agent for foreign company FDA registration
  • Pre-approval inspection support
  • Submission supplement, amendment, & annual report preparation & filing

Contract Manufacturing

We provide contract manufacturing services for companies who want to out-source their manufacturing of bio/submission batches and/or commercial batches in the US or countries such China & India. Wherever you prefer your products to be manufactured, we can find you a cGMP compliant & major regulatory agencies inspected facility for your product.

We regularly evaluate new business development opportunities, including in-licensing, out-licensing, product acquisitions, and strategic alliances.