PEAK Consulting Services is a cGMP compliance consulting firm that partners with both start-ups and established companies in regulated Life Sciences to develop, implement, assess, and improve the policies, procedures and processes necessary to accomplish cGMP compliance. With nearly 50 years of combined experience, PEAK’s Principal Consultants work to understand the unique needs of clients (based on their specific technologies and business operations, resource constraints etc.) so that, together, a tailored, efficient, and effective compliance program can be achieved.
Our experience spans a wide range of regulated products and global regulatory authorities and includes:
- design, development, and implementation of entire quality systems.
- start-up of new and renovated facilities.
- introduction of new products (including support for development, validation, approval and commercialization).
- support during regulatory inspections, responses, submissions, and remediation; and
- GMP transitions (such as those required when entering new markets with different GMP compliance expectations).
2625 N. Loop Drive, Suite 2628
Ames, IA 50010