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    Clinical regulatory services are an important support for all phases of Clinical Trials. With interdisciplinary teams and extensive internal resources companies are flexible and responsible for the smooth running of Clinical Research. The team of regulatory investigators responds to any demand and crisis to avoid issues with non compliances associated with a clinical study. Some major regulatory affairs services are Clinical trial authorizations (CTA), Competent authority meetings, Due diligenc

    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
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    01 Quotient Sciences (1)

    02 Renejix (1)

    03 Arcinova (1)

    04 Azidus Laboratories (1)

    05 Chiltern International Ltd (7)

    06 Cliantha Research (1)

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    08 Greenleaf Health Inc (2)

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    Quotient Sciences

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    REGULATORY SUBMISSIONS FOR CLINICAL TRIALS

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    Quotient Sciences' team possesses an in-depth understanding of the evolving clinical trial regulatory environment in Europe & the US, ensuring the production of high-quality dossiers, submission & approval process for Phase I clinical trial applications.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs

    Regulatory Submissions for Clinical Trials

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    Renejix

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      REGULATORY SUPPORT

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      Renejix offers customized regulatory affairs services for global markets and supports the full product lifecycle. Its regulatory specialists are experienced in handling a wide range of products including small molecules, NCEs & established dosage forms.

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      Pharma Service: Clinical Trials

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      Regulatory Support

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        STRATEGIC REGULATORY SERVICES

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        Our regulatory consulting team serves clients around the globe from biotech startups to big pharma as well as the research, investment, and legal firms that serve them.

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        Pharma Service: Clinical Trials

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        Lovelace Scientific Resources

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          REGULATORY AFFAIRS

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          We always ensure we are in line with the latest regulations and compliance guidelines. We thoroughly assess participant safety and ensure that the participants are committed and motivated to complete their study.

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          Pharma Service: Clinical Trials

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          PAREXEL International Corporation

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          REGULATORY OUTSOURCING SERVICES

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          Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

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          PPD

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          GLOBAL REGULATORY AFFAIRS SERVICES

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          PPD provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.

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          KAI Research

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          REGULATORY SERVICES

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          We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets.

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          Pharma Service: Clinical Trials

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          Litera Microsystems

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            DOCXTOOLS

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            DocXtool for Life Sciences is a Microsoft Word toolbar that accelerates the creation, review, and formatting of your electronic common technical document (eCTD), helping get your documents submission-ready faster.

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            TFS International AB

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              REGULATORY AFFAIRS STRATEGY

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              The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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              Greenleaf Health Inc

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                REGULATORY POLICY GUIDANCE

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                Greenleaf Health Inc. offers various services such as: Analysis of FDA policies and processes; User fee requirements; Advisory committee analysis; Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures.

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                TFS International AB

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                  INTERACTION WITH REGULATORY AGENCIES WORLD-WIDE

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                  The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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                  TFS International AB

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                    ORPHAN DRUG DESIGNATIONS

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                    The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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                    Greenleaf Health Inc

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                      REGULATORY GUIDANCE

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                      Greenleaf provides corporate insight on: FDA inspection, compliance and enforcement processes; FDA organization and structure as they relate to compliance functions and decisions; Impact of compliance-related legislation, regulations and guidance; FDA trends and priorities

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                      Chiltern International Ltd

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                        CLINICAL TRIAL AUTHORIZATIONS (CTA)

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                        Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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                        Chiltern International Ltd

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                          IND / IDE / BLA APPLICATIONS

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                          Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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                          MPI Research Inc

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                            REGULATORY RECORD

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                            MPI Research is known for its on-time delivery in meeting the IND and NDA submission filing goals of its Sponsors. We have substantial experience conducting studies in accordance with domestic and international regulatory agencies, including FDA, EPA, USDA, OECD, ICH, and JMHW.

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                            Chiltern International Ltd

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                              REIMBURSEMENT

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                              Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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                              Nutrasource

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                                REGULATORY APPLICATIONS & PRODUCT APPROVALS

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                                Our regulatory team stays abreast of ever changing regulations in the North American market. Our clients have diverse portfolios often crossing different regulatory categories.

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                                Chiltern International Ltd

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                                  SAFETY RISK MINIMIZATION PLANS

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                                  Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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                                  Chiltern International Ltd

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                                    SCIENTIFIC ADVICE, PROTOCOL ASSISTANCE

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                                    Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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                                    Chiltern International Ltd

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                                      SUITABILITY FOR REGISTRATION

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                                      Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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                                      TransPerfect

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                                        REGULATORY CONSULTING SERVICES

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                                        eCTD preparation and review, global CTA submissions, Packaging and labeling translation

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                                        Nutrasource

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                                          CLINICAL REGULATORY AFFAIRS

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                                          Our regulatory team stays abreast of ever changing regulations in the North American market. We take the stress out trying to understand the differences in regulations, classification and requirements between Canada and the United States.

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                                          Chiltern International Ltd

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                                            REGULATORY CONSULTING

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                                            Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products.

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                                            Dalmia

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                                              REGULATORY AFFAIRS

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                                              DRDL is providing an effective strategy of Pharmaceutical APIs, Finished Formulation and New medical device registration in India with the help of our network partner in the segment.

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                                              Azidus Laboratories

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                                                REGULATORY SERVICES

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                                                Azidus offers preparation of regulatory dossiers for semi-regulated & regulated markets, preparation of dossiers in CTD format for Market Authorization in various countries, review & preparation of all modules of CTD for regulatory submission.

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                                                ICBio Clinical Research Pvt Ltd

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                                                REGULATORY AFFAIRS

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                                                ICBio being one of the best CRO in India provides regulatory services to facilitate all stages of drug development. We provide a wide range of Regulatory Writing Services & project management services across clinical & post marketing stages.

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                                                Arcinova

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                                                  REGULATORY CONSULTING SERVICES

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                                                  We offer regulatory & consultancy services to support our clients at every stage of their project whether you require help preparing regulatory dossiers or data assessment.

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                                                  Nuvisan GmbH

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                                                  REGULATORY SERVICES

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                                                  Nuvisan provides a wide range of regulatory services such as Regulatory Support to Clinical Trials (IMPDs, Preparation & submission of CTAs) Regulatory Strategy & Development, Preparation of Application Dossiers in CTD format.

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                                                  Prorelix Research

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                                                    REGULATORY & PHARMACOVIGILANCE SERVICES

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                                                    ProRelix’s regulatory & pharmacovigilance services include clinical sections of common technical documents (CTDs) & new drug applications (NDAs), risk management plans, periodic safety update reports (PSUR) along with benefit risk evaluation reports.

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                                                    Cliantha Research

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                                                      REGULATORY SERVICES FOR CLINICAL TRIALS

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                                                      Cliantha Research offers comprehensive services including regulatory submissions, phase II-III clinical trials, feasibility studies, project management, site management, data management and statistics.

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