GXP Consultants Regulatory Affairs professionals are qualified, experienced and committed to providing full support throughout the process for the preparation of Regulatory Submissions for products manufactured by firms including:
BIOLOGICS / BIOPHARMACEUTICALS
MEDICAL DEVICE AND DIAGNOSTICS
ACTIVE PHARAMCEUTICAL INGREDIENTS (API)
GXP Consultants Regulatory Affairs professionals have a wealth of experience and expertise gained through holding key positions both within industry and Regulatory agencies. This breadth of knowledge coupled with the ongoing involvement in the development and interpretation of new and existing regulations through peer-group meetings and discussions means that GXP Consultants are able to offer unique solutions to client regulatory challenges.
GXP Consultants provide Regulatory Services in all three ICH territories following both the harmonized and individual territory routes as required. GXP Consultants provide regulatory support in a number of areas which include, but are not limited to the following:
- Strategic Regulatory Guidance and Support for the development and implementation of a Regulatory Plan to meet Commercial Goals.
- Guidance and Support to ensure Regulatory Compliance both within the USA and the rest of the world. Compliance to regulations for the manufacture, processing, labeling, distribution, and marketing of pharmaceuticals, biopharmaceuticals, biotechnology-derived products, medical device and diagnostics, active pharmaceutical ingredients (API), food and dietary supplements products
- Preparation and review of documents for the submission of regulatory documents (IND, CTX, BLA, MAA, Comparability Protocols)
- Preparation of Regulatory Submissions (BLA, eBLA, CTD, MAA) for global product approval
- Management of Regulatory Submission Programs in terms of document quality and timely delivery
- Expertise in the legal strategy for approval pathways
- Preparation and review of responses to Regulatory Questions internationally, including the European Agency for the Evaluation of Medicinal Products (EMEA) and the authorized review bodies for medical devices
- Maintenance of the Regulatory File
- Designated point of contact between Regulatory Agencies and clients
- Training in the preparation for and handling of Regulatory Audits
- Development of recovery plans following Regulatory Action / Consent Decree
- Client representation with regards to the approval of controlled substances involving both the U.S. Drug Enforcement Administration (DEA) and FDA
Further details of specifically tailored Regulatory Support functions are available following a preliminary discussion.
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Tustin, CA 92780