We have the capacities and the expertise to develop an API or Formulation right from early stages to manufacturing.
At ASolution, our capabilities offer you full API development and CGMP scale up services for clinical supply material. Our cGMP development facility supports quantities for Phase I studies and our cGMP mini pilot plant and cGMP pilot plant ensure quantities for Phase II and Phase III trials. So no matter what stage you are at ASolution is there for your needs.
Regulatory requirements, Documentation, Quality Systems are ingrained right from the pre clinical stage and all our process are tailor made to suit your needs.
We ensure that there is the highest level of transparency and quality for you and the regulatory authorities. Our process includes but are not limited to
Determination of CQAs and CPPs
Implementation of DoE and QbD techniques
Preservation of all Data to ensure retrieval at a moments notice