Services

Services

We provide a focused approach to the pharmaceutical & clinical development of drugs, devices and biologics for regulatory submissions.

We have an extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, bioanalysis, formulation, process, production, validation), outsourcing, CRO oversight & regulatory interactions, document preparation, review & filings.


Our Services Include:

Learn more about Pre-Clinical and Clinical Development

Pre-Clinical & Clinical Development We provide Legal strategies and patent development, Clinical protocol development and study designs for phases I through IV, BA and BE clinical approaches and protocol development, PK / PD modeling and simulation,Medical writing, Biostatistical and statistical approaches, Formulation and process evaluation and more. Learn More

Learn more about Registration Submissions Support

Registration Submissions & Support
We provide experience & support with many regulatory submissions. Including IND, DMF, Annual Reports, PSUR, NDA, BLA, PMA, ANDA, eCTD and more.
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Learn more about GxP and Regulatory Consultancy

GxP (GMP, GCP, GLP) & Regulatory Consultancy
We provide rapid, comprehensive & effective advice to clients on a broad range of regulatory & technical issues. As well as implementation of a compliant quality management system, Advice on legal and regulatory issues including, Patent challenges, Citizen’s petitions, Litigation, Assistance with responses to regulatory inspections and more. Learn More

Learn more about CRO Qualification

CRO Qualification
We can assist you in your search for the appropriate contract research organization (CRO) or by performing audits on your behalf to any specified GxP standard. We can assess potential contract services for Clinical supplies, Production, Packaging, Testing and more. Learn More

Learn more about Preparatory regulatory audits

Preparatory regulatory audits
We have assisted clients to prepare for an imminent regulatory inspection by conducting one or more “practice” regulatory audits in advance of the pending “actual” FDA, EMA, etc. regulatory visit. Learn More

Learn more about Due Diligence Audits

Due Diligence Audits
We assist pharmaceutical companies, investment banks & private venture capitalists in the process of due diligence for potential acquisitions, buy-ins, joint ventures & other investment projects. We perform in-depth assessment of the regulatory compliance status of companies or projects.
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