EXPERTISE
Consulting Services
For biologics, pharmaceuticals, and medical devices, we provide full-service regulatory and product development consultancy. Our large and small clients benefit from our comprehensive expertise of Nonclinical, Clinical, CMC, and Medical Device Consultants.
Pharmaceutical and Biologics Consulting
Assess and give direction on all parts of administrative procedure for item improvement
Support clients creating biologics, little particles, gadgets, biosimilars and blend items
Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) entries
Represent clients in contacts with the Food and Drug Administration (FDA).Provide a ‘FDA-style’ assessment of submissions for clients.
Assist with FDA and Advisory Committee meetings preparations.
Provide guidance on regulatory choices and possible paths..
Creating a regulatory strategy or aid in the improvement.
Original IND, NDA, BLA, MF, and OD applications, amendments, and supplements are written, reviewed, and published.
Experience in biosimilar product development
ANDA and 505(b)(2) applications are supported.
Clinical gap analysis, product development plans, and due diligence evaluations are all examples of clinical gap analyses.
Requests for orphan drug designation, fast track/breakthrough therapy requests, and iPSP authoring.
Clinical data review in the FDA manner
Support for medicines and biologics in clinical trials
Clinical trial design and oversight for CROs or individual researchers
Regulatory application preparation and evaluation
Product development strategies focused on risk
Contract services supervision
Design, installation, and upgrading of production systems for small molecules, biologics, and biosimilars.
GMP and GLP facility compliance, as well as GCP compliance
Assessments of gaps and PAI readiness
Availability in the marketplace
Audits of data (integrity and validation)