Bio-Chem: New Registration and Regulation Services

Bio-Chem recently expanded it’s services to include Pharmaceutical and Medical Device registration and regulation services in the US and Europe. The company provides GxP, Validation, Engineering, Quality Assurance, project management services & consultancy for companies from the pharmaceutical, biotechnology, medical device, cosmetics and food industries.

Bio-Chem’s registration and regulation services include:

• Regulatory services/consultancy for FDA/CE • Regulatory strategy for product development pre and post marketing • Regulatory assessment (gap analysis) of data and documents required for regulatory submissions • Preparation, review and management of meeting with health authorities • Registration of Medical Device at the IMH • Combination products registration and regulation • Medical device quality system regulation • 510(k)s, PMAs, IDEs (Investigational Device Exemptions) • CMC consulting for APIs and Drug Products (DPs) process development, scale ups, GMP production, analytical methods qualification & validation • CMC file establishment/review • CMC consulting for APIs and Drug Products (DPs) specifications setting up (final products) and In Process Control specifications (IPC) • CMC consulting and accompaniment of APIs and Drug products (DPs) processes technology transfer to CMOs • CMC section (section 7) of the Pre-INDs, INDs, NDAs writing

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