Solutions

Innovative, compliant, and global pharmaceutical services.

At Sidmex Inovia, we deliver contract manufacturing (CDMO), specialty pharmaceutical exports, and regulatory dossier services. With a supply network in 180+ countries, we ensure quality, compliance, and timely delivery for healthcare providers, governments, and patients worldwide.

3S solutions

Contract Manufacturing (CDMO)

We deliver scalable, cost-effective, and GMP-compliant contract manufacturing services for both generic and specialty medicines.

Our CDMO solutions include:

Formulation Development – tailored to international market demands.
Commercial-Scale Manufacturing – ensuring consistency, quality, and cost efficiency.
Regulatory-Compliant Production – meeting WHO, GMP, and international guidelines.
Flexibility – supporting small, mid, and large-volume production requirements.

With Sidmex Inovia as your CDMO partner, you gain end-to-end support from development to distribution, ensuring faster market launches and reliable supply.

Specialty Pharmaceutical Exports

We specialize in sourcing and exporting hard-to-access medicines, including rare disease drugs, orphan drugs, biologics, oncology treatments, and vaccines.

Our export services cover:

Global Distribution to 180+ countries.
Hospital, Government & NGO Supplies – supporting tenders, charities, and institutions.
Cold Chain Logistics – validated packaging and continuous monitoring for temperature-sensitive products.
Rare & Orphan Drugs – ensuring patient access where treatments are otherwise unavailable.

Through our global supply network, we ensure patients, hospitals, and governments receive critical medicines on time, every time.

Dossier & Stability Studies

Our regulatory and technical expertise helps pharmaceutical companies expand into new markets with confidence.

We offer:

Regulatory-Ready Dossiers (CTD/eCTD format) for faster approvals.
Pharmacovigilance Services to maintain drug safety compliance.
Stability Testing Studies under ICH guidelines to ensure long-term efficacy and safety.
Market Expansion Support – enabling smooth entry into regulated and semi-regulated markets.

Sidmex Inovia provides the documentation, studies, and compliance solutions that ensure your products meet the highest international regulatory standards.

Impact Stories

Discover how we empower CDMOs, speciality pharma exporters, and public sector tenderers to overcome regulatory, supply chain, and market access barriers. These real-world stories show how we transform complex challenges into growth, compliance, and international reach.

Rapid Early Access & Regulatory Enablement

Challenge:
The CDMO partner had developed biologic fills that needed export to multiple regulated markets. They faced time-to-market delays because of variable regulatory requirements, import/export licensing, and cold-chain validation. They lacked a unified export strategy and compliance across regions, which was slowing business growth and preventing them from winning international contracts.

Year: 2024

Approach:
We built a Regulatory Export Enablement Program: harmonised the CDMO’s documentation to meet EMA, USFDA, Health Canada, and APAC regulatory export standards; audited and upgraded cold-chain packaging and validation; secured export licences and certificates; trained internal teams in regulatory compliance; implemented a system for tracking and ensuring GMP / GDP compliance across borders.

Industry: Biologics & Specialty Manufacturing

Outcome:
Within 8 months, the CDMO opened export to 12 additional regulated markets, increasing export revenue by ~40%. They cut regulatory-related delays by over 50%, improved their cold-chain compliance score across audits, and won three new international contracts. Their reputation as a reliable global biologics supplier was solidified, enhancing competitiveness and positioning in the speciality pharma export space.

Lifecycle Continuity & Geographic Expansion

Challenge:
The firm had solid licensed presence in EU markets but minimal reach in Middle East, North Africa, and parts of Southeast Asia. Moreover, regulatory registrations in some countries had lapsed or were incomplete. Export obstacles (licensing, documentation, local partner agreements) and lack of compliant labeling hindered their ability to tender for government contracts in those regions.

Year: 2023

Approach:
We implemented an Export Lifecycle & Tender Readiness Program: carried out regulatory gap analysis in target regions; reactivated lapsed registrations; adapted product labeling and packaging to local regulatory and language requirements; facilitated partnerships with local distributors for government tender compliance; prepared dossiers for government procurement tenders; ensured compliance with GMP, import-permit, tariffs, and customs.

Industry: Hospital-use / Injectable Products

Outcome:
In 14 months, the firm achieved registration or export permission in 10 new countries, won 5 government tenders, and saw export revenue grow by 35%. Their tender-award success rate improved by over 60%, risk of supply disruption was reduced, and their footprint in emerging markets expanded.

CDMO serving government & public health contracts in Latin America

Challenge:
Governments needed comparative medicines / standard-treatment products for inclusion in public health tenders / procurement programs. The CDMO had inconsistent supply of comparator products, lengthy lead times due to import licensing, and high carry/storage costs. Some supplies failed to meet tender spec requirements (labeling, regulatory registration), which threatened disqualification from tenders.

Year: 2021

Approach:
We deployed a Tender-Ready Supply Chain Strategy: identified comparator sources with compliant regulatory standing; established regional warehouses with fresh expiry inventory; harmonised labeling & packaging to meet government tender specifications; ensured import license and registration status in tendering countries; optimized customs & logistics workflows; offered “on-demand” dispatch to match tender schedules.

Contract Manufacturing / Public Health Supplies

Outcome:
The CDMO improved its bid-win rate for government tenders by 70%, reduced comparator sourcing & storage costs by 45%, and cut lead time for tender-delivery by 40%. They fulfilled multiple large government contracts on time, compliance issues were eliminated, and they became a preferred supplier in public health procurement directories.