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We provide regulatory services with a track record of supporting regulatory approvals for oral dosage forms in US, Europe, etc. We ensure registration & post-approval strategies, regulatory agency inquiries & inspections and lifecycle management support

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Our Regulatory team provides compliance & regulatory support by managing documentation creation, review and submission while our Compliance group manages our Factory Compliance Programs, CMO management and facility inspections.

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Bachem also has a strong regulatory background and we are well prepared to fully support you with the required regulatory documentation such as drug master files (DMFs)

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Formulation and Finished Products Business Unit offers a variety of products from various therapeutic areas for both Pharmaceutical as well Veterinary with an extensive experience in the negotiation, documentation, inspections and other requirements.

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We offer scientific and regulatory services for the pharmaceutical industry and our suppliers (APIs and finished drugs, human and veterinary), primarily in the areas GMP, audits and inspections as well as regulatory affairs (eCTD).

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Established in Nov 1980, Kemimac (S) Ptd Ltd started as a distributor for active pharmaceutical ingredients, pharmaceutical excipients and healthcare related finished products. Kemimac has evolved to become a supplies partner to many manufacturers, research facilities and health institutions

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Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.

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Wavelength offers complete regulatory support to its customers throughout the product life cycle, starting from early development, through filing and commercial sales, to assure market leadership and sustainability.

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Eurofins CDMO regulatory experts will draft, review and manage the necessary documents to enable the building of Common Technical Document (CTD) for product registration and life-cycle submissions.

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Lesvi offers the complete range of Neuraxpharm’s FDF products (quality generics, pharmaceuticals and nutraceuticals) including access to our regulatory dossiers.

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Given the strong experience of Neuraxpharm's APIs manufacturing plant with the most demanding clients, Inke is able to provide full support to its clients.

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Orofino Pharmaceuticals Group can provide full regulatory and technical support for the transfer and validation of products in all of its plants. The technical expertise is available for the development & improvement of formulations and processes.

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Our regulatory expertise compile the registration dossiers (Product Quality Part) related to operations performed by our technical experts in Formulation, Process development and validation, Analytical development and validation, ICH stability studies.

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Over the years, from representing local businesses in the Pharmaceutical Industry, we have grown to represent manufacturers and distributors globally; and in the process, developed a network so comprehensive that it defines who we are and how we work as well.

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Madras Pharma has a distinguished regulatory department experienced in submitting more than 100 dossiers in all different formats (as required by the respective country) and getting approvals from both regulated and semi regulated countries.

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CRMO can assist your company with FDA pre and post approval inspections, regulatory interpretation & submissions such as DMFs to the US FDA & EU Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, etc